STA - FREE PS CALIBRATOR

K092113 · Diagnostica Stago, Inc. · JIX · Nov 13, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092113
• Device Name: STA - FREE PS CALIBRATOR
• Applicant: Diagnostica Stago, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

Device Story

STA® - Free PS Calibrator kit consists of four lyophilized human plasma vials containing defined quantities of free protein S, buffer, and stabilizers. Used in clinical laboratory settings with STA® line IVD analyzers (STA-R®, STA Compact®) to establish calibration curves for immuno-turbidimetric free protein S assays. Reconstituted with water by laboratory technicians; loaded onto analyzers to enable quantitative measurement of free protein S in patient samples. Output is a calibration curve used by the analyzer to calculate patient protein S levels, aiding in the assessment of congenital or acquired protein S deficiency and associated thrombo-embolism risk.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies performed across multiple lots and instruments (STA-R, STA Compact) showed total CVs ranging from 1.7% to 7.6%. Stability confirmed for 4 hours reconstituted on-board and 18 months lyophilized at 2-8°C.

Technological Characteristics

Lyophilized human plasma; contains buffer and stabilizers. Immuno-turbidimetric calibration principle. Designed for use with STA® line IVD analyzers. Traceable to NIBSC International Standard 03/228.

Indications for Use

Indicated for use as calibrator plasmas for the calibration of free protein S assays on STA® line IVD analyzers. For prescription use only.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• HemosIL™ Calibration Plasma (k041905)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k092113

B. Purpose for Submission:
New device

C. Measurand:
Free Protein S

D. Type of Test:
Quantitative immuno-turbidimetric method

E. Applicant:
DIAGNOSTICA STAGO, INC.

F. Proprietary and Established Names:
STA® - Free PS Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibrator, Multi-Analyte Mixture
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use(s):
STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.
2. Indication(s) for use:
Same as Intended Use
3. Special conditions for use statement(s):
For Prescription Use Only
4. Special instrument requirements:
STA® - Free PS Calibrator kit is for use with the STA® - Liatest® Free PS kit and STA® product line of IVD analyzers (STA-R® and STA Compact®).

I. Device Description:
The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immuno-turbidimetric method for free protein S assay, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®. The calibrator kit consists of four (4) calibrators. Each calibrator is composed of lyophilized human plasma containing a well defined quantity of free protein S, buffer, and stabilizers.

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# Substantial Equivalence Information:

1. Predicate device name(s):
HemosIL™ Calibration Plasma
2. Predicate K number(s):
k041905
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | STA® - Free PS Calibrator | HemosIL™ Calibration Plasma |
| Intended Use | STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS | HemosIL Calibration Plasma is intended for the calibration of coagulation assays on IL and ELECTRA coagulation systems. |
| Parameters | Free Protein S | Protein S |
| Design | Lyophilized human plasma reconstituted with water used in IVD analyzers | Same |
| Storage | 2-8°C | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Instrumentation | STA-R® and STA Compact® | IL and ELECTRA coagulation systems. |
| Parameters | | Antithrombin, Single Factors, Fibrinogen, Plasmin Inhibitor, Plasminogen, von Willebrand Factor, Protein C, PT, APTT, TT |

# K. Standard/Guidance Document Referenced (if applicable):

Not applicable

# L. Test Principle:

Protein S is a physiological inhibitor of the coagulation process. It acts as the cofactor of activated protein C. The congenital or acquired deficiency of protein S increases the risk of thrombo-embolism. The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immuno-turbidimetric method for free protein S assays.

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The free protein S level determinations were performed in eight different series on each calibrator level with the same instrument (STA-R®) using two different lots of STA® - Liatest® Free PS kit. Concurrently, the free protein S level determinations were also performed in eight different series on each

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calibrator level with two different instruments (STA Compact® and STA-R®) using one lot of STA® - Liatest® Free PS kit. All tests were run within two to three weeks. A target value was established for each calibrator level; Reagent 1: 14%, Reagent 2: 29%, Reagent 3: 57%, Reagent 4: 95%. Total CV% for both studies is as follows:

Inter-Assay Lot Reproducibility Data for STA® - Free® PS Calibrator

| STA® - Liatest® Free PS | Free Protein S Level (%) | | | |
| --- | --- | --- | --- | --- |
| | Reagent 1 | Reagent 2 | Reagent 3 | Reagent 4 |
| Lot 1 CV (%) | 6.7 | 3.7 | 1.7 | 2.6 |
| Lot 2 CV (%) | 5.0 | 3.7 | 2.5 | 1.9 |

Inter-Instrument Reproducibility Data for STA® - Free® PS Calibrator

| Instrument | Free Protein S Level (%) | | | |
| --- | --- | --- | --- | --- |
| | Reagent 1 | Reagent 2 | Reagent 3 | Reagent 4 |
| STA-R® CV (%) | 6.7 | 3.7 | 1.7 | 2.6 |
| STA Compact® CV (%) | 7.6 | 3.6 | 2.8 | 2.6 |

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Value assignment: For each calibrator level, the free protein S value corresponds to the mean of a minimum of 24 determinations performed with a minimum of 3 instruments, using at least two different lots of STA® - Liatest® Free PS. The determinations are carried out by a minimum of two laboratory technicians.

Traceability: The STA® - Free PS Calibrators are determined against a secondary standard, International Standard 03/228 for free protein S established in 2006 by the National Institute for Biological Standards and Control (NIBSC).

Stability: Three different lots of calibrators (Reagent 1, 2, 3, and 4) were used in the stability studies. Three vials each of Reagent 1, 2, 3, and 4 were reconstituted and stored for 4 hours on both analyzers (STA Compact and STA-R). In addition, freshly reconstituted reagents from the same three lots were run using the STA® - Liatest® Free PS assay. The reconstituted stability study result supports the claim of remaining stable for 4 hours on board the STA line of IVD analyzers. In the lyophilized state, the calibrator plasmas remain stable for a duration of 18 months from the date of manufacture when stored at 2-8°C.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

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Not applicable

b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Expected values are manufacturing lot specific. An Assay Value Insert (AVI) is provided with each box of calibrators. Target values are as follows: Reagent 1: 15%, Reagent 2: 31%, Reagent 3: 61%, Reagent 4: 101%.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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