StarDust MC15

Chemistry parameters ALAT(GPT) FS (IFCC mod.)

GPT
Kinetic
Monoreagent application Order information
WL1 340
Units U/l Cat. No. 1 2701 .. .. …
Temperature 37
Factor 1745
N of Read 5 Notes
Interval 30
Delay 120 1. Please refer to the package insert for ALAT(GPT) FS (IFCC
mod.) for detailed information about the test on the following:
Lim Abs 0.7 min
Lin. Limit 250
Clinical Relevance
Norm High 41 Method and Principle
Composition and Stability of the Reagents
Norm Low 0
Specimens
Decimals 0 Calibrators and Controls
Performance Characteristics regarding
Sample Vol 50
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 4 WEEKS AT 2 - 8° C
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero **The Performance of a StarDust MC15/FC as a semi
(blank) automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent Sample Quality of results strongly depends on manual test
(Reading zone) (Sample zone) performance of the user.
Samples 500 µl 50 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
5 minutes at 37°C

Go into programme no. 1 . Input the number of samples and the

initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

1 845 2701 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters ALBUMIN FS

ALBU
EP

Order information
WL1 630
WL2 546 Cat. No. 1 0220 .. .. …
Units g/dl
Temperature 37 Notes
Std 5.0
Factor 1. Please refer to the package insert for Albumin FS for
Lin. Limit 6.0 detailed information about the test on the following:

Norm High 5.2

Clinical Relevance
Norm Low 3.5 Method and Principle
Decimals 1 Composition and Stability of the Reagents
Specimens
Sample Vol 5 Calibrators and Controls
Reagent Vol 500 Performance Characteristics regarding
- Measuring Range
Reac. Time 180 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:
2. Manufactured by
Reagent ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany
See package insert for reagent stability

Pipette into the cuvette strips in the appropriate way.

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 500 µl technical specifications (see manual).
Std (Optional) 500 µl 5 µl Quality of results strongly depends on manual test
Samples 500 µl 5 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the incubating position for 5 minutes.

Go into programme no. 3 . Input the number of samples and the

initial position for them and whether a recalibration is needed.

Place the cuvette strip in the reading position and press READ

2 845 0220 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters ALBUMIN IN URINE/CSF FS

(Microalbumin)
MALB
Urine/CSF application
Multi Std - Differential

WL1 405
Order information
WL2
Units mg/l
Cat. No. 1 0242 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Alb U/CSF Notes
Point 3 / Conc *Level 2 TruCal Alb U/CSF
Point 4 / Conc *Level 3 TruCal Alb U/CSF 1. Please refer to the package insert for Albumin in Urine/CSF
Point 5 / Conc *Level 4 TruCal Alb U/CSF FS *Microalbumin for detailed information about the test on
the following:
Point 6 / Conc *Level 5 TruCal Alb U/CSF
Readings per standard 1 Clinical Relevance
Readings per sample 1 Method and Principle
Composition and Stability of the Reagents
Temperature 37 Specimens
Lin. Limit 333 Calibrators and Controls
Performance Characteristics regarding
Norm High 20 - Measuring Range
Norm Low 0 - Specificity/Interferences
- Sensitivity/Limit of Detection
Decimals 1 - Precision (Reproducibility, Repeatability)
Sample Vol 20 - Method Comparison
Reference Ranges
Reagent Vol 400 + 80 Literature
Delay 0
Reac. Time 180 2. Manufactured by
DiaSys Diagnostic Systems,
*Input by user
Alte Strasse 9, 65558 Holzheim, Germany
MC15
Procedure:

Reagents are ready to use

**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Pipette into the cuvette strips in the appropriate way. Samples Quality of results strongly depends on manual test
are dispensed directly into the reading zone performance of the user.
This application was verified at DiaSys and has subsequently
Reagent 1 Sample been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone) by use.
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 31. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ
3 845 0242 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters ALKALINE PHOSPHATASE FS DGKC

ALP
Kinetic
Monoreagent Application Order information
WL1 405
Units U/l Cat. No. 1 0401 .. .. …
Temperature 37
Factor 2757
N of Read 5
Notes
Interval 30
Delay 60 1. Please refer to the package insert for
Alkaline phosphatase FS DGKC for detailed
Lim Abs 1.5 max information about the test on the following:
Lin. Limit 700
Norm High 258 Clinical Relevance
Method and Principle
Norm Low 0
Composition and Stability of the Reagents
Decimals 0 Specimens
Calibrators and Controls
Sample Vol 10
Performance Characteristics regarding
Reagent Vol 500 - Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 4 WEEKS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero
(blank) **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent Sample technical specifications (see manual).
(Reading zone) (Sample zone) Quality of results strongly depends on manual test
Samples 500 µl 10 µl performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C validated by use.

Go into programme no. 4 . Input the number of samples and the

initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

4 845 0401 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters ALKALINE PHOSPHATASE FS

IFCC 37° C

ALP
Kinetic
Monoreagent Application
WL1 405
Order information
Units U/l
Temperature 37
Cat. No. 1 0441 .. .. …
Factor 2757
N of Read 5
Interval 30 Notes
Delay 60
Lim Abs 1.5 max 1. Please refer to the package insert for
Lin. Limit 700 Alkaline phosphatase FS IFCC for detailed
information about the test on the following:
Norm High 128
Norm Low 42
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
MC15 - Precision (Reproducibility, Repeatability)
- Method Comparison
Procedure: Reference Ranges
Literature
For Monoreagent mix 4 parts R1 + 1 part R2

STABILITY: 4 WEEKS AT 2 - 8° C 2. Manufactured by

5 DAYS AT 15 - 25° C DiaSys Diagnostic Systems,
The Monoreagent must be protected from light! Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero
(blank)

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Samples 500 µl 10 µl technical specifications (see manual).
Quality of results strongly depends on manual test
performance of the user.
Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Go into programme no. 5 . Input the number of samples and the validated by use.
initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

5 845 0411 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters -AMYLASE CC FS

AMYL
Kinetic
Monoreagent Application
Order information
WL1 405
Units U/l Cat. No. 1 0501 .. .. …
Temperature 37
Factor 4554
N of Read 4 Notes
Interval 60
Delay 120 1. Please refer to the package insert for -Amylase CC FS
Lim Abs 1.4 Max for detailed information about the test on the following:

Lin. Limit 1800

Clinical Relevance
Norm High 100 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 10 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 6 MONTHS AT 2 - 8° C
4 WEEKS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero **The Performance of a StarDust MC15/FC as a semi
(blank) automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent Sample Quality of results strongly depends on manual test
(Reading zone) (Sample zone) performance of the user.
Samples 500 µl 10 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
5 minutes at 37°C

Go into programme no. 6 . Input the number of samples and the

initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

6 845 0501 10 02 71

September 2007/4
StarDust MC15

Chemistry parameters APOLIPOPROTEIN A1 FS

APOA
Multi Std – Differential

WL1 578
Order information
WL2
Units mg/dl
Cat. No. 1 7102 .. .. …
Number of standards 3
Point 1/ Conc *
Notes
Point 2/ Conc *
Point 3/ Conc *
1. Please refer to the package insert for Apoliporotein A1 FS
Readings per standard 2 for detailed information about the test on the following:
Readings per sample 1
Temperature 37 Clinical Relevance
Method and Principle
Lin. Limit 250 Composition and Stability of the Reagents
Norm High 190 Specimens
Calibrators and Controls
Norm Low 110 Performance Characteristics regarding
Decimals 1 - Measuring Range
- Specificity/Interferences
Sample Vol 20** - Sensitivity/Limit of Detection
Reagent Vol 400 + 80 - Precision (Reproducibility, Repeatability)
- Method Comparison
Delay 30
Reference Ranges
Reac. Time 180 Literature
*Input by user
2. Manufactured by
MC15 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany
Procedure:

Reagents are ready to use

**Samples/Standards are pre-diluted 1+5 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples **The Performance of a StarDust MC15/FC as a semi
are dispensed directly into the reading zone automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent 1 Sample Quality of results strongly depends on manual test
(Reading zone) (Reading zone) performance of the user.
Blank 400 µl This application was verified at DiaSys and has subsequently
Stds (Optional) 400 µl 20 µl been tested at a variety of customer laboratories and
Samples 400 µl 20 µl validated by use.

Place the cuvette strip in the incubating position for 10 minutes

Go into the Apo A1 programme no. 32. Input the number of

samples and the initial position for them and whether a
recalibration is needed.

Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

7 845 7102 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters APOLIPOPROTEIN B FS

APOB
Multi Std - Differential

WL1 340
Order information
WL2
Units mg/dl
Cat. No. 1 7112 .. .. …
Number of standards 3
Point 1/ Conc *
Point 2/ Conc * Notes
Point 3/ Conc *
Readings per standard 2
1. Please refer to the package insert for Apoliporotein B FS
Readings per sample 1 for detailed information about the test on the following:
Temperature 37
Lin. Limit 250 Clinical Relevance
Method and Principle
Norm High 155 Composition and Stability of the Reagents
Norm Low 75 Specimens
Calibrators and Controls
Decimals 1 Performance Characteristics regarding
Sample Vol 20** - Measuring Range
- Specificity/Interferences
Reagent Vol 400 + 80 - Sensitivity/Limit of Detection
Delay 30 - Precision (Reproducibility, Repeatability)
- Method Comparison
Reac. Time 180 Reference Ranges
*Input by user Literature

MC15 2. Manufactured by
DiaSys Diagnostic Systems,
Procedure: Alte Strasse 9, 65558 Holzheim, Germany.
Reagents are ready to use
**SamplesStandards are pre-diluted 1+5 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples
are dispensed directly into the reading zone **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent 1 Sample technical specifications (see manual).
(Reading zone) (Reading zone) Quality of results strongly depends on manual test
Blank 400 µl performance of the user.
Stds (Optional) 400 µl 20 µl This application was verified at DiaSys and has subsequently
Samples 400 µl 20 µl been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the incubating position for 10 minutes

Go into the Apo B programme no. 33. Input the number of

samples and the initial position for them and whether a
recalibration is needed.

Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

8 845 7112 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters ASAT(GOT) FS (IFCC mod.)

GOT
Kinetic
Monoreagent Application Order information
WL1 340
Units U/l Cat. No. 1 2601 .. .. …
Temperature 37
Factor 1745
N of Read 5 Notes
Interval 30
Delay 120 1. Please refer to the package insert for
ASAT(GOT) FS (IFCC Mod) for detailed
Lim Abs 0.7 min
information about the test on the following:
Lin. Limit 250
Norm High 37 Clinical Relevance
Norm Low 0 Method and Principle
Composition and Stability of the Reagents
Decimals 0 Specimens
Sample Vol 50 Calibrators and Controls
Performance Characteristics regarding
Reagent Vol 500 - Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 4 WEEKS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany.
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero
(blank) **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent Sample technical specifications (see manual).
(Reading zone) (Sample zone) Quality of results strongly depends on manual test
Samples 500 µl 50 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the incubating position and leave it for been tested at a variety of customer laboratories and
5 minutes at 37°C validated by use.

Go into programme no. 2 . Input the number of samples and the

initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

9 845 2601 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters ANTISTREPTOLYSIN O FS

ASO
Multi Std - FxT

WL1 546
Order information
WL2
Units IU/ml
Cat. No. 1 7012 .. .. …
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal ASO Notes
Point 3 / Conc *Level 2 TruCal ASO
Point 4 / Conc *Level 3 TruCal ASO 1. Please refer to the package insert for Antistreptolysin O FS
Point 5 / Conc *Level 4 TruCal ASO for detailed information about the test on the following:
Point 6 / Conc
Clinical Relevance
Readings per standard 1 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 400 Performance Characteristics regarding
- Measuring Range
Norm High 200 - Specificity/Interferences
Norm Low 0 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 0
- Method Comparison
Sample Vol 10 Reference Ranges
Literature
Reagent Vol 400 + 80
Delay 30
2. Manufactured by
Reac. Time 180 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples performance of the user.
are dispensed directly into the reading zone This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1 Sample
by use.
(Reading zone) (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 10 µl
Samples 400 µl 10 µl

Place the cuvette strip in the incubating position for 5 minutes

Go into the programme no. 34. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip immediately in the reading position and

press READ

10 845 7012 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters BICARBONATE FS

CO2
FxT

Order information
WL1 405
Units mmol/l Cat. No. 1 0950 .. .. …
Temperature 37
Std 30
Factor Notes
Interval 390
Delay 30 1. Please refer to the package insert for Bicarbonate FS for
detailed information about the test on the following:
Lim Abs Min 0
Lin. Limit 50
Clinical Relevance
Norm High 29 Method and Principle
Norm Low 22 Composition and Stability of the Reagents
Specimens
Decimals 1 Calibrators and Controls
Sample Vol 5 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagent ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
See package insert for reagent stability

Pipette into the cuvette strips in the appropriate way.

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 500 µl technical specifications (see manual).
Std (Optional) 500 µl 5 µl Quality of results strongly depends on manual test
Samples 500 µl 5 µl performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Go into the programme no. 35. Input the number of samples validated by use.
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

11 845 0950 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters BILIRUBIN AUTO DIRECT FS

BILD
Diff
Order information
WL1 546
WL2 630 Cat. No. 1 0821 .. .. …
Units mg/dl
Temperature 37
Std 2.62
Notes
Factor
Lin. Limit 10.0 1. Please refer to the package insert for Bilirubin Auto Direct FS
for detailed information about the test on the following:
Norm High 0.2
Norm Low 0.0 Clinical Relevance
Decimals 2 Method and Principle
Composition and Stability of the Reagents
Sample Vol 50 Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 0 - Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature

Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
**The Performance of a StarDust MC15/FC as a semi
Std (Optional) 400 µl 50 µl automated photometer unit is mainly characterized by it´s
Samples 400 µl 50 µl technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 7 . Input the number of samples and the been tested at a variety of customer laboratories and
initial position for them and whether a recalibration is needed. validated by use.
Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

12 845 0821 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters BILIRUBIN AUTO TOTAL FS

BILT
Diff

Order information
WL1 546
WL2 630 Cat. No. 1 0811 .. .. …
Units mg/dl
Temperature 37
Std 4.47 Notes
Factor
Lin. Limit 10.0 1. Please refer to the package insert for Bilirubin Auto Total
FS for detailed information about the test on the following:
Norm High 1.2
Norm Low 0.1
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 50
Specimens
Reagent Vol * 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 0
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:

Reagents are ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 50 µl
Samples 400 µl 50 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Place the cuvette strip in the mixing position and press MIX
Quality of results strongly depends on manual test
performance of the user.
Go into programme no. 8 . Input the number of samples and the
This application was verified at DiaSys and has subsequently
initial position for them and whether a recalibration is needed.
been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

13 845 0811 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters COMPLEMENT C3c FS

C3
Multi Std - Differential

WL1 340
WL2
Order information
Units mg/dl
Cat. No. 1 1802 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein Notes
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein 1. Please refer to the package insert for Complement C3c FS
Point 5 / Conc *Level 4 TruCal Protein for detailed information about the test on the following:
Point 6 / Conc *Level 5 TruCal Protein
Clinical Relevance
Readings per standard 2
Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37
Calibrators and Controls
Lin. Limit 400 Performance Characteristics regarding
- Measuring Range
Norm High 180
- Specificity/Interferences
Norm Low 90 - Sensitivity/Limit of Detection
Decimals 0 - Precision (Reproducibility, Repeatability)
- Method Comparison
Sample Vol 10 Reference Ranges
Reagent Vol 500 + 100 Literature

Delay 0
2. Manufactured by
Reac. Time 300 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany d.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples
performance of the user.
are dispensed directly into the reading zone
This application was verified at DiaSys and has subsequently
Reagent 1 Sample been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone) by use.
Blank 500 µl
Stds (Optional) 500 µl 10 µl
Samples 500 µl 10 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 36. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

14 845 1802 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters COMPLEMENT C4 FS

C4
Multi Std - Differential

WL1 340
WL2
Order information
Units mg/dl
Cat. No. 1 1812 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein Notes
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein 1. Please refer to the package insert for Complement C4 FS
Point 5 / Conc *Level 4 TruCal Protein for detailed information about the test on the following:
Point 6 / Conc *Level 5 TruCal Protein
Clinical Relevance
Readings per standard 2
Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37
Calibrators and Controls
Lin. Limit 90 Performance Characteristics regarding
- Measuring Range
Norm High 40
- Specificity/Interferences
Norm Low 10 - Sensitivity/Limit of Detection
Decimals 0 - Precision (Reproducibility, Repeatability)
- Method Comparison
Sample Vol 10 Reference Ranges
Reagent Vol 400 + 80 Literature

Delay 0
2. Manufactured by
Reac. Time 300 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples
performance of the user.
are dispensed directly into the reading zone
This application was verified at DiaSys and has subsequently
Reagent 1 Sample been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone) by use.
Blank 400 µl
Stds (Optional) 400 µl 10 µl
Samples 400 µl 10 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 37. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ
15 845 1812 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters CALCIUM AS FS

CALC
EP

Order information
WL1 670
WL2 578 Cat. No. 1 1130 .. .. …
Units mg/dl
Temperature 37
Std 10.0 Notes
Factor
Lin. Limit 25.0 1. Please refer to the package insert for Calcium AS FS for
detailed information about the test on the following:
Norm High 10.3
Norm Low 8.6
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 5 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 9 . Input the number of samples and the been tested at a variety of customer laboratories and
initial position for them and whether a recalibration is needed. validated by use.

Place the cuvette strip in the reading position and press READ

16 845 1130 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters CALCIUM P FS

CALC
Diff

Order information
WL1 670
WL2 546 Cat. No. 1 1181 .. .. …
Units mg/dl
Temperature 37
Std 10.0 Notes
Factor
Lin. Limit 25.0 1. Please refer to the package insert for Calcium P FS for
detailed information about the test on the following:
Norm High 10.3
Norm Low 8.6
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 180
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 5 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX
performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 38 . Input the number of samples and
been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is
validated by use.
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

18 845 1181 10 02 71

September 2009/5
StarDust MC15

Chemistry parameters CHOLINESTERASE FS

CLIN
Kinetic

Order information
WL1 405
Units U/l Cat. No. 1 1401 .. .. …
Temperature 37
Factor 55016
N of Read 4 Notes
Interval 60
Delay 120 1. Please refer to the package insert for Cholinesterase FS
for detailed information about the test on the following:
Lim Abs 0.1 min
Lin. Limit 25000
Clinical Relevance
Norm High 11500 Method and Principle
Norm Low 3930 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 10 Performance Characteristics regarding
- Measuring Range
Reagent Vol 400 + 100 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone) **The Performance of a StarDust MC15/FC as a semi
Blank 400 µl automated photometer unit is mainly characterized by it´s
Std (Optional) 400 µl 10 µl technical specifications (see manual).
Samples 400 µl 10 µl Quality of results strongly depends on manual test
performance of the user.
Place the cuvette strip in the mixing position and press MIX This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
3 minutes at 37°C

Go into the programme no. 39. Input the number of samples

and the initial position for them.

Take out the cuvette strip out of the incubating position and add
100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

19 845 1401 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters CHLORIDE FS

CL
EP

Order information
WL1 500
WL2 630 Cat. No. 1 1200 .. .. …
Units mmol/l
Temperature 37
Std 100 Notes
Factor
Lin. Limit 130 1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following:
Norm High 108
Norm Low 96
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 180
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 3 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 11 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

20 845 1200 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters CHOLESTEROL FS

CHOL
EP

Order information
WL1 500
WL2 630 Cat. No. 1 1300 .. .. …
Units mg/dl
Temperature 37
Std 200 Notes
Factor
Lin. Limit 380 1. Please refer to the package insert for Cholesterol FS for
detailed information about the test on the following:
Norm High 200
Norm Low 0
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 10 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 12 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

21 845 1300 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters CK-MB FS

Substrate start with DS

CK-M
Kinetic
Substrate start DS
Order information
WL1 340
Units U/l Cat. No. 1 1651 .. .. …
Temperature 37
Factor 4127
N of Read 4 Notes
Interval 60
Delay 180 1. Please refer to the package insert for CK-MB FS for
Lim Abs 1.4 max detailed information about the test on the following:
Lin. Limit 1000
Clinical Relevance
Norm High 24 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 20 Performance Characteristics regarding
- Measuring Range
Reagent Vol 400 + 100 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:
2. Manufactured by
Reagent 1: Mix 1 part of CK-MB DS with 20 parts R1. DiaSys Diagnostic Systems,
STABILITY: 6 days at 2 – 8 ° C Alte Strasse 9, 65558 Holzheim, Germany.
24 hrs at 15 – 25 ° C

Reagent 2: R2 is ready to use

Pipette into the cuvette strips in the appropriate way.

**The Performance of a StarDust MC15/FC as a semi
Reagent 1 Sample automated photometer unit is mainly characterized by it´s
(Reading zone) (Sample zone) technical specifications (see manual).
Blank 400 µl Quality of results strongly depends on manual test
Std (Optional) 400 µl 20 µl performance of the user.
Samples 400 µl 20 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the mixing position and press MIX validated by use.

Place the cuvette strip in the incubating position and leave it for
15 minutes at 37°C

Go into the programme no. 40. Input the number of samples

and the initial position for them.

Take out the cuvette strip out of the incubating position and add
100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

22 845 1651 10 02 71

May 2008/2
StarDust MC15

Chemistry parameters CK-MB FS

CK-M
Kinetic
Monoreagent Application Order information
WL1 340
Units U/l Cat. No. 1 1651 .. .. …
Temperature 37
Factor 8254
N of Read 4 Notes
Interval 60
Delay 300 1. Please refer to the package insert for CK-MB FS for
detailed information about the test on the following:
Lim Abs 1.4 Max
Lin. Limit 1000
Clinical Relevance
Norm High 24 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 1 Calibrators and Controls
Sample Vol 20 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. The stability of the reagent on board the analyser is at
For Monoreagent mix 4 parts R1 + 1 part R2 least one month provided that contamination and
evaporation are avoided.
STABILITY: 2 WEEKS AT 2 - 8° C
24 HOURS AT 15 - 25° C 3. Manufactured by
The Monoreagent must be protected from light! DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
A free initial cuvette position must be left to perform the optical
zero (blank). Pipette 500 µl of reagent into the reagent position
in the cuvette strips.

Place the cuvette strip in the incubating position and leave it for
15 minutes at 37°C
Pipette 20 µl sample into the sample position
Incubate for a further 2 – 3 minutes at 37°C
Go into programme no. 13 . Input the number of samples and
the initial position for them.
Place the cuvette strip in the mixing position and press MIX
**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
validated by use.

Place the cuvette strip in the reading position and press READ

23 845 1651 10 02 71

January 2008/3
StarDust MC15

Chemistry parameters CK-NAC FS

CK-N
Kinetic
Monoreagent Application
Order information
WL1 340
Units U/l Cat. No. 1 1601 .. .. …
Temperature 37
Factor 4127
N of Read 4 Notes
Interval 60
Delay 180 1. Please refer to the package insert for CK-NAC FS for
Lim Abs 1.4 Max detailed information about the test on the following:
Lin. Limit 1000
Clinical Relevance
Norm High 195 Method and Principle
Norm Low 24 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 20 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:
2. The stability of the reagent on board the analyser is at
For Monoreagent mix 4 parts R1 + 1 part R2 least one month provided that contamination and
evaporation are avoided.
STABILITY: 3 WEEKS AT 2 - 8° C
2 DAYS AT 15 - 25° C
The Monoreagent must be protected from light! 3. Manufactured by
DiaSys Diagnostic Systems GmbH
A free initial cuvette position must be left to perform the optical Alte Strasse 9, 65558 Holzheim, Germany
zero (blank). Pipette 500 µl of reagent into the reagent position
in the cuvette strips.

Place the cuvette strip in the incubating position and leave it for
15 minutes at 37°C
Pipette 20 µl sample into the sample position
Incubate for a further 2 – 3 minutes at 37°C
Go into programme no. 14 . Input the number of samples and
the initial position for them.
Place the cuvette strip in the mixing position and press MIX
**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
validated by use.

Place the cuvette strip in the reading position and press READ

24 845 1601 10 02 71

January 2008/3
StarDust MC15

Chemistry parameters CREATININE PAP FS

CREA
Diff

Order information
WL1 546
WL2 630 Cat. No. 1 1759 .. .. …
Units mg/dl
Temperature 37
Std 2.0
Notes
Factor
Lin. Limit 30 1. Please refer to the package insert for Creatinine PAP FS
for detailed information about the test on the following:
Norm High 1.3
Norm Low 0.5 Clinical Relevance
Decimals 2 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10 Specimens
Reagent Vol 400 + 200 Calibrators and Controls
Performance Characteristics regarding
Delay 180 - Measuring Range
Reac Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature

Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
**The Performance of a StarDust MC15/FC as a semi
(Reading zone) (Sample zone)
automated photometer unit is mainly characterized by it´s
Blank 400 µl
technical specifications (see manual).
Std (Optional) 400 µl 10 µl
Quality of results strongly depends on manual test
Samples 400 µl 10 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX been tested at a variety of customer laboratories and
validated by use.
Go into programme no. 42 . Input the number of samples and
the initial position for them and whether a recalibration is
needed

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 200 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

26 845 1759 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters CREATININE PAP FS

CREA
Diff

Order information
WL1 546
WL2 630 Cat. No. 1 1759 .. .. …
Units mg/dl
Temperature 37
Std 2.0
Notes
Factor
Lin. Limit 160 1. Please refer to the package insert for Creatinine PAP FS
for detailed information about the test on the following:
Norm High 1.3
Norm Low 0.5 Clinical Relevance
Decimals 2 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10 Specimens
Reagent Vol 400 + 200 Calibrators and Controls
Performance Characteristics regarding
Delay 180 - Measuring Range
Reac Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature

Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
**The Performance of a StarDust MC15/FC as a semi
(Reading zone) (Sample zone)
automated photometer unit is mainly characterized by it´s
Blank 400 µl
technical specifications (see manual).
Std (Optional) 400 µl 10 µl
Quality of results strongly depends on manual test
Samples 400 µl 10 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX been tested at a variety of customer laboratories and
validated by use.
Go into programme no. 42 . Input the number of samples and
the initial position for them and whether a recalibration is
needed

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 200 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

26 845 1759 10 02 71

April 2011/6
StarDust MC15

Chemistry parameters
CREATININE FS
CREA
FxT
Monoreagent application
WL1 500
Units mg/dl Order information
Temperature 37
Std 2.0 Cat. No. 1 1711 .. .. …
Factor
Interval 120
Notes
Delay 30
Lim Abs Max 2.5
1. Please refer to the package insert for Creatinine FS for
Lin. Limit 7.5 detailed information about the test on the following:
Norm High 1.3
Norm Low 0.6 Clinical Relevance
Method and Principle
Decimals 1 Composition and Stability of the Reagents
Sample Vol 50 Specimens
Calibrators and Controls
Reagent Vol 500 Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
MC15 - Precision (Reproducibility, Repeatability)
- Method Comparison
Procedure: Reference Ranges
Literature
For Monoreagent mix 4 parts R1 + 1 part R2
2. Manufactured by
STABILITY: 5 HOURS AT 15 – 25 °C DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone) **The Performance of a StarDust MC15/FC as a semi
Blank 500 µl automated photometer unit is mainly characterized by it´s
Std (Optional) 500 µl 50 µl technical specifications (see manual).
Samples 500 µl 50 µl Quality of results strongly depends on manual test
performance of the user.
Place the cuvette strip in the incubating position and leave it for This application was verified at DiaSys and has subsequently
5 minutes at 37°C been tested at a variety of customer laboratories and
validated by use.
Go into programme no. 15 . Input the number of samples and
the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

25 845 1711 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters CRP U-hs

High sensitive (hs) application
CRP
Multi Std - FxT

Order information
WL1 500
WL2
Cat. No. 1 7045 .. .. …
Units mg/l
Number of standards 6
Point 1/ Conc NaCl – 0 Notes
Point 2 / Conc *Level 1 TruCal CRP hs
Point 3 / Conc *Level 2 TruCal CRP hs
1. Please refer to the package insert for CRP U-hs FS for
Point 4 / Conc *Level 3 TruCal CRP hs detailed information about the test on the following:
Point 5 / Conc *Level 4 TruCal CRP hs
Point 6 / Conc *Level 5 TruCal CRP hs Clinical Relevance
Method and Principle
Readings per standard 2 Composition and Stability of the Reagents
Readings per sample 1 Specimens
Calibrators and Controls
Temperature 37 Performance Characteristics regarding
Lin. Limit 20 - Measuring Range
- Specificity/Interferences
Norm High 5 - Sensitivity/Limit of Detection
Norm Low 0 - Precision (Reproducibility, Repeatability)
- Method Comparison
Decimals 2 Reference Ranges
Sample Vol 20 Literature
Reagent Vol 200 + 200
2. Manufactured by
Delay 60 DiaSys Diagnostic Systems,
Interval 240 Alte Strasse 9, 65558 Holzheim, Germany.
*Input by user

MC15
Procedure: **The Performance of a StarDust MC15/FC as a semi
Reagents are ready to use automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
performance of the user.
Pipette into the cuvette strips in the appropriate way. This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1+2 Sample by use.
(Reading zone) (Sample zone)
Blank 200 µl + 200 µl
Stds (Optional) 200 µl + 200 µl 20 µl
Samples 200 µl + 200 ml 20 µl

Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C
Go into the programme no. 44. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

28 845 7045 10 42 71

May 2008/4
StarDust MC15

Chemistry parameters CRP FS

CRP
Multi Std - Differential

WL1 340
Order information
WL2
Units mg/l
Cat. No. 1 7002 .. .. …
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal CRP Notes
Point 3 / Conc *Level 2 TruCal CRP
Point 4 / Conc *Level 3 TruCal CRP 1. Please refer to the package insert for CRP FS for detailed
Point 5 / Conc *Level 4 TruCal CRP information about the test on the following:
Point 6 / Conc *Level 5 TruCal CRP
Clinical Relevance
Readings per standard 2 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 280 Performance Characteristics regarding
- Measuring Range
Norm High 5 - Specificity/Interferences
Norm Low 0 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 0
- Method Comparison
Sample Vol 20 Reference Ranges
Literature
Reagent Vol 400 + 80
Delay 0
2. Manufactured by
Reac. Time 180 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples performance of the user.
are dispensed directly into the reading zone This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1 Sample
by use.
(Reading zone) (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 43. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

27 845 7002 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters D-DIMER FS

DMER
Multi Std - FxT

WL1 578
Order information
WL2
Units µg/ml
Cat. No. 1 7268 .. .. …
Number of standards 6
Point 1/ Conc Level 1 Diluent
Point 2 / Conc *Level 2 Notes
Point 3 / Conc *Level 3
Point 4 / Conc *Level 4 1. Please refer to the package insert for D-Dimer FS for
Point 5 / Conc *Level 4 detailed information about the test on the following:
Point 6 / Conc *Level 6
Clinical Relevance
Readings per standard 1 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 8.7 Performance Characteristics regarding
- Measuring Range
Norm High 0.5 - Specificity/Interferences
Norm Low 0 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 2
- Method Comparison
Sample Vol 10 Reference Ranges
Literature
Reagent Vol 300 + 100
Delay 30
2. Manufactured by
Reac. Time 180 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples performance of the user.
are dispensed directly into the reading zone This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1 Sample
by use.
(Reading zone) (Reading zone)
Blank 300 µl
Stds (Optional) 300 µl 10 µl
Samples 300 µl 10 µl

Place the cuvette strip in the incubating position for 5 minutes

Go into the programme no. X. Input the number of samples and
the initial position for them and whether a recalibration is
needed.

Add 100 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip immediately in the reading position and

press READ

845 7268 10 02 71

October 2008/1
StarDust MC15

Chemistry parameters FREE CHOLESTEROL FS

FCHO
EP
Order information
WL1 500
WL2 630 Cat. No. 1 1360 .. .. …
Units mg/dl
Temperature 37
Std 200
Notes
Factor
Lin. Limit 250 1. Please refer to the package insert for Free Cholesterol FS
for detailed information about the test on the following:
Norm High 200
Norm Low 0 Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10 Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600 - Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.

Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 10 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 46 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

30 845 1360 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters FERRITIN FS

FERR
Multi Std - FxT

WL1 578
Order information
WL2
Units ng/ml
Cat. No. 1 7059 .. .. …
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Ferritin Notes
Point 3 / Conc *Level 2 TruCal Ferritin
Point 4 / Conc *Level 3 TruCal Ferritin 1. Please refer to the package insert for Ferritin FS for
Point 5 / Conc *Level 4 TruCal Ferritin detailed information about the test on the following
Readings per standard 1
Clinical Relevance
Readings per sample 1 Method and Principle
Temperature 37 Composition and Stability of the Reagents
Specimens
Lin. Limit 1000 Calibrators and Controls
Norm High 300 Performance Characteristics regarding
- Measuring Range
Norm Low 30
- Specificity/Interferences
Decimals 1 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Sample Vol 10
- Method Comparison
Reagent Vol 200 + 100 Reference Ranges
Literature
Delay 30
Interval 180
2. Manufactured by
*Input by user DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
MC15
Procedure:

Reagents are ready to use

**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by
Pipette into the cuvette strips in the appropriate way. it´s technical specifications (see manual).
Quality of results strongly depends on manual test
Reagent 1+2 Sample performance of the user.
(Reading zone) (Sample zone) This application was verified at DiaSys and has
Blank 200 µl + 100 µl subsequently been tested at a variety of customer
Stds (Optional) 200 µl + 100 µl 10 µl laboratories and validated by use.
Samples 200 µl + 100 ml 10 µl

Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C
Go into the programme no. 47. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

31 45 7059 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters GAMMA GT FS (IFCC stand)

GGT
Kinetic
Monoreagent Application Order information
WL1 405
Units U/l Cat. No. 1 2801 .. .. …
Temperature 37
Factor 1309
N of Read 4 Notes
Interval 60
Delay 60 1. Please refer to the package insert for Gamma-GT FS (Szasz
Lim Abs 1.500 max mod./ IFCC stand) for detailed information about the test on the
following:
Lin. Limit 230
Norm High 55 Clinical Relevance
Norm Low 0 Method and Principle
Composition and Stability of the Reagents
Decimals 0 Specimens
Sample Vol 50 Calibrators and Controls
Performance Characteristics regarding
Reagent Vol 500 - Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 4 WEEKS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany.
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero
(blank) **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent Sample technical specifications (see manual).
(Reading zone) (Sample zone) Quality of results strongly depends on manual test
Samples 500 µl 50 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the incubating position and leave it for been tested at a variety of customer laboratories and
5 minutes at 37°C validated by use.

Go into programme no. 17 . Input the number of samples and

the initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

33 845 2801 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters GAMMA GT FS (Szasz mod.)

GGT
Kinetic
Monoreagent Application Order information
WL1 405
Units U/l Cat. No. 1 2801 .. .. …
Temperature 37
Factor 1158
N of Read 4 Notes
Interval 60
Delay 60 1. Please refer to the package insert for Gamma-GT FS (Szasz
Lim Abs 1.500 max mod./ IFCC stand) for detailed information about the test on the
following:
Lin. Limit 230
Norm High 49 Clinical Relevance
Norm Low 0 Method and Principle
Composition and Stability of the Reagents
Decimals 0 Specimens
Sample Vol 50 Calibrators and Controls
Performance Characteristics regarding
Reagent Vol 500 - Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 4 WEEKS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany.
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero
(blank) **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent Sample technical specifications (see manual).
(Reading zone) (Sample zone) Quality of results strongly depends on manual test
Samples 500 µl 50 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the incubating position and leave it for been tested at a variety of customer laboratories and
5 minutes at 37°C validated by use.

Go into programme no. 16 . Input the number of samples and

the initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

34 845 2801 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters GLDH FS DGKC

GLDH
Kinetic

Order information
WL1 340
Units U/l Cat. No. 1 2411 .. .. …
Temperature 37
Factor 1485
N of Read 4
Notes
Interval 60
Delay 30 1. Please refer to the package insert for GLDH FS DGKC for
the detailed information about the test on the following:
Lim Abs 0.3 min
Lin. Limit 120 Clinical Relevance
Method and Principle
Norm High 7 Composition and Stability of the Reagents
Norm Low 0 Specimens
Calibrators and Controls
Decimals 1
Performance Characteristics concerning;
Sample Vol 50 Measuring Range
Specificity/Interferences
Reagent Vol 400 + 100
Sensitivity/Limit of Detection
Precision (Reproducibility, Repeatability)
Method Comparison
Reference Ranges
MC15 Literature

Procedure: 2. Manufactured by
DiaSys Diagnostic Systems,
Reagents are ready to use Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 400 µl technical specifications (see manual).
Quality of results strongly depends on manual test
Std (Optional) 400 µl 50 µl
performance of the user.
Samples 400 µl 50 µl
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the mixing position and press MIX validated by use.
Place the cuvette strip in the incubating position and leave it for
3 minutes at 37°C

Go into the programme no. 49. Input the number of samples

and the initial position for them and whether a recalibration is
needed.

Take out the cuvette strip out of the incubating position and add
100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

35 845 2411 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters GLUCOSE GOD FS

GLUC
EP

Order information
WL1 500
WL2 630 Cat. No. 1 2500 .. .. …
Units mg/dl
Temperature 37
Std 100 Notes
Factor
Lin. Limit 400 1. Please refer to the package insert for Glucose GOD FS for
detailed information about the test on the following:
Norm High 115
Norm Low 70
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 10 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 18 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

36 845 2500 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters GLUCOSE HEXOKINASE FS

GLUC
EP
Monoreagent application Order information
WL1 340
WL2 630 Cat. No. 1 2511 .. .. …
Units mg/dl
Temperature 37
Std 100 Notes
Factor
Lin. Limit 500 1. Please refer to the package insert for Glucose Hexokinase
FS for detailed information about the test on the following:
Norm High 115
Norm Low 70
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 300
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 3 MONTHS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany.
2 WEEKS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way.

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 500 µl technical specifications (see manual).
Std (Optional) 500 µl 5 µl Quality of results strongly depends on manual test
Samples 500 µl 5 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the incubating position for 5 minutes.

Go into programme no. 19 . Input the number of samples and

the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

37 845 2511 10 02 71

September 2007/3
StarDust MC15
Chemistry parameters
HBA1
one HbA1c FS
Multi Std - EP
3 Component System

WL1 630
WL2 Select pos 8 ( (empty)
Units % Order information
Number of standards 5
Point 1/ Conc NaCl - 0 Cat. No. 1 3329 .. .. …
Point 2 / Conc *Level 1 TruCal HbA1c
Point 3 / Conc *Level 2 TruCal HbA1c
Notes
Point 4 / Conc *Level 3 TruCal HbA1c
Point 5 / Conc *Level 4 TruCal HbA1c
1. Please refer to the package insert for oneHbA1c FS for
Readings per standard 1 detailed information about the test on the following:
Readings per sample 1
Temperature 37 Clinical Relevance
Method and Principle
Lin. Limit 15 Composition and Stability of the Reagents
Norm High 6 Specimens
Calibrators and Controls
Norm Low 4
Performance Characteristics regarding
Decimals 2 - Measuring Range
- Specificity/Interferences
Sample Vol 10
- Sensitivity/Limit of Detection
Reagent Vol 300 + 100 + 50 - Precision (Reproducibility, Repeatability)
- Method Comparison
Reac. Time 240
Reference Ranges
Literature
*Input by user
MC15
2. Manufactured by
Procedure: DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Reagents are ready to use

The end point incubation must be switched on before

measurement. To do this go to 4: Utilities,
option 12: E.P. Incubation, select 1:Y

Pipette into the cuvette strips in the appropriate way.
Pipette 300 µl Reagent 1 (reading zone)
Incubate for 5 minutes in the incubation block
Go into the programme no. 50. Input the number of samples
and the initial position for them and whether a recalibration is
needed.
**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
by use.

Pipette 10 µl Sample (Sample zone)

Mix and incubate at 37°C for 3 minutes in the incubation block

After 3 min of incubation add 100 µl R2 into the reading zone in
the cuvettes

Mix and incubate at 37°C for a further 2 minutes in the

incubation block

After 2 min of incubation add 50 µl R3 into the sample zone in

the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

38 845 3329 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters HDL-C IMMUNO FS

HDL
Diff

Order information
WL1 578
WL2 670 Cat. No. 1 3521 .. .. …
Units mg/dl
Temperature 37
Std 99.8 Notes
Factor
Lin. Limit 180 1. Please refer to the package insert for HDL-C Immuno FS
Norm High 80 for detailed information about the test on the following:

Norm Low 35
Clinical Relevance
Decimals 0 Method and Principle
Sample Vol 5 Composition and Stability of the Reagents
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Delay 280 Performance Characteristics regarding
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 5 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Place the cuvette strip in the mixing position and press MIX Quality of results strongly depends on manual test
performance of the user.
Go into programme no. 20 . Input the number of samples and This application was verified at DiaSys and has subsequently
the initial position for them and whether a recalibration is been tested at a variety of customer laboratories and
needed. validated by use.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

40 845 3521 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters IMMUNOGLOBULIN A FS

IGA
Multi Std - Differential

WL1 578
Order information
WL2
Units mg/dl
Cat. No. 1 7202 .. .. …
Number of standards 4
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 2 TruCal Protein Notes
Point 3 / Conc *Level 4 TruCal Protein
Point 4 / Conc *Level 5 TruCal Protein 1. Please refer to the package insert for Immunoglobulin A FS
Readings per standard 2 for detailed information about the test on the following:
Readings per sample 1
Clinical Relevance
Temperature 37 Method and Principle
Lin. Limit 900 Composition and Stability of the Reagents
Specimens
Norm High 400 Calibrators and Controls
Norm Low 70 Performance Characteristics regarding
- Measuring Range
Decimals 0
- Specificity/Interferences
Sample Vol 30** - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Reagent Vol 400 + 80
- Method Comparison
Delay 0 Reference Ranges
Literature
Reac. Time 300
*Input by user
This application has been prozone tested up to 9200 mg/dl and no 2. Manufactured by
ambiguous results were observed. DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
MC15
Procedure:

Reagents are ready to use

**The Performance of a StarDust MC15/FC as a semi
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Pipette into the cuvette strips in the appropriate way. Samples Quality of results strongly depends on manual test
are dispensed directly into the reading zone performance of the user.
This application was verified at DiaSys and has subsequently
Reagent 1 Sample
been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone)
by use.
Blank 400 µl
Stds (Optional) 400 µl 30 µl
Samples 400 µl 30 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the IgA programme no. 52. Input the number of
samples and the initial position for them and whether a
recalibration is needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

41 845 7202 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters IMMUNOGLOBULIN E FS

IGE
Multi Std - FxT

WL1 578
Order information
WL2
Units IU/ml
Cat. No. 1 7239 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal IgE Notes
Point 3 / Conc *Level 2 TruCal IgE
Point 4 / Conc *Level 3 TruCal IgE 1. Please refer to the package insert for Immunoglobulin E FS
Point 5 / Conc *Level 4 TruCal IgE for detailed information about the test on the following:
Point 6 / Conc *Level 5 TruCal IgE
Clinical Relevance
Readings per standard 1 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 1000 Performance Characteristics regarding
- Measuring Range
Norm High 100 - Specificity/Interferences
Norm Low 0 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 1
- Method Comparison
Sample Vol 5 Reference Ranges
Literature
Reagent Vol 200 + 100
Delay 30
2. Manufactured by
Interval 180 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. performance of the user.
This application was verified at DiaSys and has subsequently
Reagent 1+2 Sample
been tested at a variety of customer laboratories and validated
(Reading zone) (Sample zone)
by use.
Blank 200 µl + 100 µl
Stds (Optional) 200 µl + 100 µl 5 µl
Samples 200 µl + 100 ml 5 µl

Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C
Go into the programme no. 53. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

42 845 7239 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters IMMUNOGLOBULIN G FS

IGG
Multi Std - Differential

WL1 578
Order information
WL2
Units mg/dl
Cat. No. 1 7212 .. .. …
Number of standards 4
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 2 TruCal Protein Notes
Point 3 / Conc *Level 4 TruCal Protein
Point 4 / Conc *Level 5 TruCal Protein 1. Please refer to the package insert for Immunoglobulin G FS
Readings per standard 2 for detailed information about the test on the following:
Readings per sample 1
Clinical Relevance
Temperature 37 Method and Principle
Lin. Limit 3500 Composition and Stability of the Reagents
Specimens
Norm High 1600 Calibrators and Controls
Norm Low 700 Performance Characteristics regarding
- Measuring Range
Decimals 0
- Specificity/Interferences
Sample Vol 20** - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Reagent Vol 400 + 80
- Method Comparison
Delay 0 Reference Ranges
Literature
Reac. Time 300
*Input by user
This application has been prozone tested up to 35000 mg/dl and no 2. Manufactured by
ambiguous results were observed. DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
MC15
Procedure:

Reagents are ready to use

**The Performance of a StarDust MC15/FC as a semi
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Pipette into the cuvette strips in the appropriate way. Samples Quality of results strongly depends on manual test
are dispensed directly into the reading zone performance of the user.
This application was verified at DiaSys and has subsequently
Reagent 1 Sample
been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone)
by use.
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the IGG programme no. 54. Input the number of
samples and the initial position for them and whether a
recalibration is needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

43 845 7212 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters IMMUNOGLOBULIN M FS

IGM
Multi Std - Differential

WL1 340
Order information
WL2
Units mg/dl
Cat. No. 1 7222 .. .. …
Number of standards 4
Point 1/ Conc NaCl – 0
Point 2 / Conc *Level 1 TruCal Protein
Point 3 / Conc *Level 3 TruCal Protein
Notes
Point 4 / Conc *Level 4 TruCal Protein
Point 5 / Conc *Level 5 TruCal Protein 1. Please refer to the package insert for Immunoglobulin M FS
for detailed information about the test on the following:
Readings per standard 2
Readings per sample 1 Clinical Relevance
Temperature 37 Method and Principle
Composition and Stability of the Reagents
Lin. Limit 800 Specimens
Norm High 230 Calibrators and Controls
Performance Characteristics regarding
Norm Low 40 - Measuring Range
Decimals 0 - Specificity/Interferences
- Sensitivity/Limit of Detection
Sample Vol 50** - Precision (Reproducibility, Repeatability)
Reagent Vol 400 + 80 - Method Comparison
Reference Ranges
Delay 0 Literature
Reac. Time 300
*Input by user 2. Manufactured by
This application has been prozone tested up to 5000 mg/dl and no DiaSys Diagnostic Systems,
ambiguous results were observed. Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl technical specifications (see manual).
Pipette into the cuvette strips in the appropriate way. Samples Quality of results strongly depends on manual test
are dispensed directly into the reading zone performance of the user.
This application was verified at DiaSys and has subsequently
Reagent 1 Sample been tested at a variety of customer laboratories and validated
(Reading zone) (Reading zone) by use.
Blank 400 µl
Stds (Optional) 400 µl 50 µl
Samples 400 µl 50 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the IgM programme no. 55. Input the number of
samples and the initial position for them and whether a
recalibration is needed.

Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

44 845 7222 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters IRON FS Ferene

IRON
Diff

Order information
WL1 578
WL2 Cat. No. 1 1911 .. .. …
Units µg/dl
Temperature 37
Std 202 Notes
Factor
Lin. Limit 270 1. Please refer to the package insert for Iron FS Ferene for
detailed information about the test on the following:
Norm High 168
Norm Low 23
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 100
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 0
- Measuring Range
Reac. Time 600 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 100 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 100 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX
performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 21 . Input the number of samples and
been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is
validated by use.
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

45 845 1911 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters LACTATE FS

LACT
Diff

Order information
WL1 340
WL2 0 Cat. No. 1 4001 .. .. …
Units mg/dl
Temperature 37
Std * Notes
Factor
Lin. Limit 120.0 1. Please refer to the package insert for Lactate FS for
detailed information about the test on the following:
Norm High 19.8
Norm Low 4.5
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol * 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 180
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
MC15 Reference Ranges
Literature
Procedure:

Reagents are ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl
Samples 400 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Place the cuvette strip in the mixing position and press MIX
Quality of results strongly depends on manual test
performance of the user.
Go into programme no. 57. Input the number of samples and
This application was verified at DiaSys and has subsequently
the initial position for them and whether a recalibration is
been tested at a variety of customer laboratories and
needed.
validated by use.
Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

46 845 4001 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters LDH FS DGKC

LDH
Kinetic
Monoreagent application Order information
WL1 340
Units U/l Cat. No. 1 4201 .. .. …
Temperature 37
Factor 8095
N of Read 5 Notes
Interval 30
Delay 60 1. Please refer to the package insert for LDH.FS DGKC for
the detailed information about the test on the following:
Lim Abs 0.700 min
Lin. Limit 2400
Clinical Relevance
Norm High 480 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 10 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 5 DAYS AT 2 - 8° C
8 HOURS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero **The Performance of a StarDust MC15/FC as a semi
(blank) automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent Sample Quality of results strongly depends on manual test
(Reading zone) (Sample zone) performance of the user.
Samples 500 µl 10 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
5 minutes at 37°C

Go into programme no. 22 . Input the number of samples and

the initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

47 845 4201 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters LDH FS IFCC

LDH
Kinetic
Monoreagent application Order information
WL1 340
Units U/l Cat. No. 1 4211 .. .. …
Temperature 37
Factor 8095
N of Read 5 Notes
Interval 30
Delay 60 1. Please refer to the package insert for LDH FS IFCC for
detailed information about the test on the following:
Lim Abs 0.900 max
Lin. Limit 1500
Clinical Relevance
Norm High 248 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 10 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 24 HOURS AT 2 - 8° C
4 HOURS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free

initial cuvette position must be left to perform the optical zero **The Performance of a StarDust MC15/FC as a semi
(blank) automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent Sample Quality of results strongly depends on manual test
(Reading zone) (Sample zone) performance of the user.
Samples 500 µl 10 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
5 minutes at 37°C

Go into programme no. 30. Input the number of samples and

the initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

48 845 4211 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters LDL-C SELECT FS

LDL
Diff

Order information
WL1 578
WL2 670 Cat. No. 1 4121 .. .. …
Units mg/dl
Temperature 37
Std * Notes
Factor
Lin. Limit 400 1. Please refer to the package insert for LDL-C Select FS for
detailed information about the test on the following:
Norm High 130
Norm Low 0
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 280
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 5 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX
performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 58 . Input the number of samples and
been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is
validated by use.
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

49 845 4121 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters LIPASE DC FS

LIPA
Kin

Order information
WL1 578
Units U/l Cat. No. 1 4321 .. .. …
Temperature 37
Std Input value
Factor Notes
N of Read 3
Interval 60 1. Please refer to the package insert for Lipase DC FS for
detailed information about the test on the following:
Delay 120
Lin. Limit 240
Clinical Relevance
Norm High 60 Method and Principle
Norm Low 0 Composition and Stability of the Reagents
Specimens
Decimals 1 Calibrators and Controls
Sample Vol 10 Performance Characteristics regarding
- Measuring Range
Reagent Vol 400 + 100 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone) **The Performance of a StarDust MC15/FC as a semi
Blank 400 µl automated photometer unit is mainly characterized by it´s
Std (Optional) 400 µl 10 µl technical specifications (see manual).
Samples 400 µl 10 µl Quality of results strongly depends on manual test
performance of the user.
Place the cuvette strip in the mixing position and press MIX This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
3 minutes at 37°C

Go into the programme no. 59. Input the number of samples

and the initial position for them and whether a recalibration is
needed.

Take out the cuvette strip out of the incubating position and add
100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

50 845 4321 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters Lp(a) 21 FS

LPA
Multi Std - FxT

WL1 670
Order information
WL2
Units mg/dl
Cat. No. 1 7139 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Lp(a) 21 Notes
Point 3 / Conc *Level 2 TruCal Lp(a) 21
Point 4 / Conc *Level 3 TruCal Lp(a) 21 1. Please refer to the package insert for Lp(a) 21 FS for
Point 5 / Conc *Level 4 TruCal Lp(a) 21 detailed information about the test on the following:
Point 6 / Conc *Level 5 TruCal Lp(a) 21
Clinical Relevance
Readings per standard 1 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 130 Performance Characteristics regarding
- Measuring Range
Norm High 30 - Specificity/Interferences
Norm Low 0 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 1
- Method Comparison
Sample Vol 10 Reference Ranges
Literature
Reagent Vol 400 + 200
Delay 30
2. Manufactured by
Interval 300 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
Premix 2 parts R1 with 1 part R2 making sufficient for the technical specifications (see manual).
number of tests Quality of results strongly depends on manual test
performance of the user.
Pipette into the cuvette strips in the appropriate way. This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1+2 Sample
by use.
premixed (Sample zone)
(Reading zone)
Blank 600 µl
Stds (Optional) 600 µl 10 µl
Samples 600 µl 10 µl

Place the cuvette strip in the incubating position and leave it for
5 minutes at 37°C
Go into the programme no. 60. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

51 845 7139 10 02 71

May 2008/3
StarDust MC15

Chemistry parameters MAGNESIUM XL FS

MAG
EP

Order information
WL1 546
WL2 670 Cat. No. 1 4610 .. .. …
Units mg/dl
Temperature 37
Std 2.00 Notes
Factor
Lin. Limit 5.00 1. Please refer to the package insert for Magnesium XL FS
for detailed information about the test on the following:
Norm High 2.6
Norm Low 1.8
Clinical Relevance
Decimals 2 Method and Principle
Composition and Stability of the Reagents
Sample Vol 5
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 180
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 3 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 23 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

52 845 4610 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters PHOSPHATE FS

PHOS
EP
Monoreagent application Order information

WL1 340 Cat. No. 1 5211 .. .. …

WL2 630
Units mg/dl
Temperature 37 Notes
Std 5.0
Factor 1. Please refer to the package insert for Phosphate FS for detailed
information about the test on the following:
Lin. Limit 30.0
Norm High 4.5 Clinical Relevance
Norm Low 2.6 Method and Principle
Composition and Stability of the Reagents
Decimals 1
Specimens
Sample Vol 5 Calibrators and Controls
Performance Characteristics regarding
Reagent Vol 500
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 1 YEAR AT 2 – 8° C

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone) **The Performance of a StarDust MC15/FC as a semi
Blank 500 µl automated photometer unit is mainly characterized by it´s
Std (Optional) 500 µl 5 µl technical specifications (see manual).
Samples 500 µl 5 µl Quality of results strongly depends on manual test
performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX
been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the incubating position for 5 minutes.

Go into programme no. 24 . Input the number of samples and

the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

55 845 5211 10 02 71

May 2008/5
StarDust MC15

Chemistry parameters RHEUMATOID FACTOR FS

RF
Multi Std - Differential

WL1 340
WL2 630
Units IU/ml
Order information
Number of standards 6
Cat. No. 1 7022 .. .. …
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal RF
Point 3 / Conc *Level 2 TruCal RF Notes
Point 4 / Conc *Level 3 TruCal RF
Point 5 / Conc *Level 4 TruCal RF 1. Please refer to the package insert for Rheumatoid Factor
Point 6 / Conc *Lavel 5 TruCal RF FS for detailed information about the test on the following:
Readings per standard 1
Clinical Relevance
Readings per sample 1 Method and Principle
Temperature 37 Composition and Stability of the Reagents
Specimens
Lin. Limit 500 Calibrators and Controls
Norm High 15 Performance Characteristics regarding
- Measuring Range
Norm Low 0
- Specificity/Interferences
Decimals 1 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Sample Vol 25
- Method Comparison
Reagent Vol 400 + 80 Reference Ranges
Delay 0 Literature

Reac. Time 300

2. Manufactured by
*Input by user DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
MC15
Procedure:

Reagents are ready to use

**The Performance of a StarDust MC15/FC as a semi
Pipette into the cuvette strips in the appropriate way. automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Reagent 1 Sample Quality of results strongly depends on manual test
(Reading zone) (Sample zone) performance of the user.
Blank (Water) 400 µl This application was verified at DiaSys and has subsequently
Stds (Optional) 400 µl 25 µl been tested at a variety of customer laboratories and validated
Samples 400 µl 25 µl by use.

Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 15 minutes
Go into the programme no. 63. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

56 845 7022 10 02 71

May 2008/6
StarDust MC15

Chemistry parameters TOTAL PROTEIN FS

T PR
Diff

Order information
WL1 546
WL2 630 Cat. No. 1 2311 .. .. …
Units g/dl
Temperature 37
Std 5.0 Notes
Factor
Lin. Limit 15.0 1. Please refer to the package insert for Total Protein FS for
detailed information about the test on the following:
Norm High 8.8
Norm Low 6.6
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 0
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 10 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX
performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 25 . Input the number of samples and
been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is
validated by use.
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

57 845 2311 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters TOTAL PROTEIN UC FS

URPR
EP

Order information
WL1 578
WL2 670 Cat. No. 1 0210 .. .. …
Units mg/l
Temperature 37
Std 1300 Notes
Factor
Lin. Limit 3000 1. Please refer to the package insert for Total Protein UC FS
for detailed information about the test on the following:
Norm High 141
Norm Low 24
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 300
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
See package insert for reagent stability Alte Strasse 9, 65558 Holzheim, Germany.

Pipette into the cuvette strips in the appropriate way.

Reagent Sample
(Reading zone) (Sample zone) **The Performance of a StarDust MC15/FC as a semi
Blank 500 µl automated photometer unit is mainly characterized by it´s
Std (Optional) 500 µl 10 µl technical specifications (see manual).
Samples 500 µl 10 µl Quality of results strongly depends on manual test
performance of the user.
Place the cuvette strip in the mixing position and press MIX This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position for 5 minutes. validated by use.

Go into the programme no. 64. Input the number of samples

and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

58 845 0210 10 52 71

May 2008/5
StarDust MC15

Chemistry parameters TRANSFERRIN FS

TRAN
Multi Std - Differential

WL1 578
Order information
WL2
Units mg/dl
Cat. No. 1 7252 .. .. …
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein Notes
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein 1. Please refer to the package insert for Transferrin FS for
Point 5 / Conc *Level 4 TruCal Protein detailed information about the test on the following:
Point 6 / Conc *Level 5 TruCal Protein
Clinical Relevance
Readings per standard 2 Method and Principle
Readings per sample 1 Composition and Stability of the Reagents
Specimens
Temperature 37 Calibrators and Controls
Lin. Limit 800 Performance Characteristics regarding
- Measuring Range
Norm High 360 - Specificity/Interferences
Norm Low 200 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
Decimals 0
- Method Comparison
Sample Vol 30** Reference Ranges
Literature
Reagent Vol 400 + 80
Delay 0
2. Manufactured by
Reac. Time 300 DiaSys Diagnostic Systems,
*Input by user Alte Strasse 9, 65558 Holzheim, Germany.

MC15
Procedure:

Reagents are ready to use **The Performance of a StarDust MC15/FC as a semi

automated photometer unit is mainly characterized by it´s
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl technical specifications (see manual).
Quality of results strongly depends on manual test
Pipette into the cuvette strips in the appropriate way. Samples performance of the user.
are dispensed directly into the reading zone This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and validated
Reagent 1 Sample
by use.
(Reading zone) (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 30 µl
Samples 400 µl 30 µl

Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 65. Input the number of samples
and the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 80 µl R2 into the sample position in all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

59 845 7252 10 02 71

May 2008/4
StarDust MC15

Chemistry parameters TRIGLYCERIDES FS

TRIG
EP

Order information
WL1 500
WL2 630 Cat. No. 1 5710 .. .. …
Units mg/dl
Temperature 37
Std 200 Notes
Factor
Lin. Limit 500 1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Norm High 200
Norm Low 0
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

Reagent ready to use 2. Manufactured by

DiaSys Diagnostic Systems,
Pipette into the cuvette strips in the appropriate way. Alte Strasse 9, 65558 Holzheim, Germany.
Reagent Sample
(Reading zone) (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl **The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Place the cuvette strip in the mixing position and press MIX technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the incubating position for 10 minutes. performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 26 . Input the number of samples and been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is validated by use.
needed.

Place the cuvette strip in the reading position and press READ

60 845 5710 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters UIBC FS

UIBC
Diff

Order information
WL1 578
WL2 Cat. No. 1 1921 .. .. …
Units µg/dl
Temperature 37
Std TruCal Notes
Factor
Lin. Limit 750 1. Please refer to the package insert for UIBC FS
for detailed information about the test on the following:
Norm High 470
Norm Low 120
Clinical Relevance
Decimals 0 Method and Principle
Composition and Stability of the Reagents
Sample Vol 30
Specimens
Reagent Vol 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 300
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample
(Reading zone) (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 30 µl **The Performance of a StarDust MC15/FC as a semi
Samples 400 µl 30 µl automated photometer unit is mainly characterized by it´s
technical specifications (see manual).
Quality of results strongly depends on manual test
Place the cuvette strip in the mixing position and press MIX
performance of the user.
This application was verified at DiaSys and has subsequently
Go into programme no. 41 . Input the number of samples and
been tested at a variety of customer laboratories and
the initial position for them and whether a recalibration is
validated by use.
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

61 845 1921 10 02 71

May 2008/2
StarDust MC15

Chemistry parameters UREA CT FS

UREA
EP

Order information
WL1 578
WL2 - Cat. No. 1 3115 .. .. …
Units mg/dl
Temperature 37 Notes
Std 50
Factor 1. Please refer to the package insert for Urea CT FS for
Lin. Limit 300 detailed information about the test on the following:

Norm High 43
Clinical Relevance
Norm Low 17 Method and Principle
Decimals 1 Composition and Stability of the Reagents
Specimens
Sample Vol 5 Calibrators and Controls
Reagent Vol * 250 + 250 Performance Characteristics regarding
- Measuring Range
Delay 0 - Specificity/Interferences
Reac. Time 300 - Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature

Procedure:
2. Manufactured by
Reagents are ready to use. Reagent 1A needs to be prepared DiaSys Diagnostic Systems,
as described Alte Strasse 9, 65558 Holzheim, Germany.

Stds/Controls/Samples must be diluted 1+1 with NaCl

Pipette into the cuvette strips in the appropriate way. Please

note samples must be dispensed directly into the reading zone
**The Performance of a StarDust MC15/FC as a semi
automated photometer unit is mainly characterized by it´s
Reagent 1A Sample
technical specifications (see manual).
(Reading zone) (Reading zone)
Quality of results strongly depends on manual test
Blank 250 µl
performance of the user.
Std (Optional) 250 µl 5 µl This application was verified at DiaSys and has subsequently
Samples 250 µl 5 µl been tested at a variety of customer laboratories and
validated by use.
Incubate for 10 mins at room temperature or 5 mins at 37°C

When the incubation is completed take out the cuvette strip and
add 250 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Incubate for 10 mins at room temperature or 5 mins at 37°C

Go into the programme no 66. Input the number of samples and

the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

63 845 3115 10 02 71

May 2008/6
StarDust MC15

Chemistry parameters UREA FS

UREA
FxT
Monoreagent application Order information
WL1 340
Units mg/dl Cat. No. 1 3101 .. .. …
Temperature 37
Std 50
Factor Notes
Interval 60
Delay 30 1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Lim. Abs. 0.5 MAX
Lin. Limit 300
Clinical Relevance
Norm High 43 Method and Principle
Norm Low 17 Composition and Stability of the Reagents
Specimens
Decimals 0 Calibrators and Controls
Sample Vol 5 Performance Characteristics regarding
- Measuring Range
Reagent Vol 500 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
For Monoreagent mix 4 parts R1 + 1 part R2 DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
STABILITY: 4 WEEKS AT 2 - 8° C
5 DAYS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way.

**The Performance of a StarDust MC15/FC as a semi
Reagent Sample automated photometer unit is mainly characterized by it´s
(Reading zone) (Sample zone) technical specifications (see manual).
Blank 500 µl Quality of results strongly depends on manual test
Std (Optional) 500 µl 5 µl performance of the user.
Samples 500 µl 5 µl This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the incubating position and leave it for validated by use.
5 minutes at 37°C

Go into programme no. 27 . Input the number of samples and

the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

62 845 3101 10 02 71

September 2007/4
StarDust MC15

Chemistry parameters URIC ACID FS TBHBA

URIC
EP
Monoreagent application Order information
WL1 546
WL2 630 Cat. No. 1 3021 .. .. …
Units mg/dl
Temperature 37
Std 6.0 Notes
Factor
Lin. Limit 20.0 1. Please refer to the package insert for Uric Acid FS TBHBA
for detailed information about the test on the following:
Norm High 8.2
Norm Low 2.3
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol 500 Calibrators and Controls
Performance Characteristics regarding
Reac. Time 600
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
MC15 - Method Comparison
Reference Ranges
Procedure: Literature

For Monoreagent mix 4 parts R1 + 1 part R2 2. Manufactured by

DiaSys Diagnostic Systems,
STABILITY: 3 MONTHS AT 2 - 8° C Alte Strasse 9, 65558 Holzheim, Germany.
2 WEEKS AT 15 - 25° C
The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way.

Reagent Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 500 µl technical specifications (see manual).
Std (Optional) 500 µl 10 µl Quality of results strongly depends on manual test
Samples 500 µl 10 µl performance of the user.
This application was verified at DiaSys and has subsequently
Place the cuvette strip in the mixing position and press MIX been tested at a variety of customer laboratories and
validated by use.
Place the cuvette strip in the incubating position for 10 minutes.

Go into programme no. 28 . Input the number of samples and

the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

64 845 3021 10 02 71

September 2007/3
StarDust MC15

Chemistry parameters URIC ACID (TOOS) FS

URIC
Diff

Order information
WL1 546
WL2 Cat. No. 1 3001 .. .. …
Units mg/dl
Temperature 37
Std 6.0 Notes
Factor
Lin. Limit 20.0 1. Please refer to the package insert for Uric Acid FS for
detailed information about the test on the following:
Norm High 8.2
Norm Low 2.3
Clinical Relevance
Decimals 1 Method and Principle
Composition and Stability of the Reagents
Sample Vol 10
Specimens
Reagent Vol * 400 + 100 Calibrators and Controls
Performance Characteristics regarding
Delay 240
- Measuring Range
Reac. Time 300 - Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
MC15 Literature
Procedure:
2. Manufactured by
Reagents are ready to use DiaSys Diagnostic Systems,
Alte Strasse 9, 65558 Holzheim, Germany.
See package insert for reagent stability

Pipette into the cuvette strips in the appropriate way.

Reagent 1 Sample **The Performance of a StarDust MC15/FC as a semi

(Reading zone) (Sample zone) automated photometer unit is mainly characterized by it´s
Blank 400 µl technical specifications (see manual).
Std (Optional) 400 µl 10 µl Quality of results strongly depends on manual test
Samples 400 µl 10 µl performance of the user.
This application was verified at DiaSys and has subsequently
been tested at a variety of customer laboratories and
Place the cuvette strip in the mixing position and press MIX
validated by use.
Go into programme no. 29 . Input the number of samples and
the initial position for them and whether a recalibration is
needed.

Place the cuvette strip in the reading position and press READ

When the reading is completed Take out the cuvette strip and
add 100 µl R2 to all the cuvettes

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

65 845 3001 10 02 71

September 2007/3