STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM

K061805 · Diagnostica Stago, Inc. · GIR · Dec 6, 2006 · Hematology

Device Facts

• Record ID: K061805
• Device Name: STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
• Applicant: Diagnostica Stago, Inc.
• Product Code: GIR · Hematology
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8950
• Device Class: Class 1

Indications for Use

The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.

Device Story

STA®-Staclot® dRVV Screen and Confirm are in vitro diagnostic reagents used on STA® line analyzers to detect lupus anticoagulants (LA) in citrated plasma. The assay utilizes the dilute Russell’s viper venom method. The Screen reagent contains low phospholipid concentrations; presence of LA prolongs clotting time. The Confirm reagent contains high phospholipid concentrations to neutralize LA, shortening the clotting time compared to the Screen. The kit includes a heparin inhibitor to neutralize heparin up to 0.8 IU/mL. Results are used by clinicians to aid in the identification of LA, which are antibodies directed against phospholipid/protein complexes. The device is intended for use in clinical laboratory settings by trained personnel.

Clinical Evidence

Bench testing only. Precision/reproducibility studies showed within-run CV < 1.0% and inter-assay CV ≤ 4.1%. Analytical specificity testing confirmed heparin neutralization up to 0.8 IU/mL and LMWH (Fragmin) up to 0.8 anti-Xa IU/mL. Method comparison study at two sites demonstrated 92% agreement with the predicate device. Reference range established using 27 normal plasmas.

Technological Characteristics

Reagents consist of freeze-dried Russell’s viper venom, phospholipids, calcium, and heparin inhibitor. Sensing principle is clotting time measurement via STA® line analyzers. Reconstituted reagent stability is 72 hours. Storage at 2-8 °C.

Indications for Use

Indicated for the detection of lupus anticoagulants (LA) in human citrated plasma. Intended for professional use in clinical laboratory settings using STA® line coagulation analyzers.

Regulatory Classification

Identification

Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

Predicate Devices

• LAC Screen and Confirm (K990302)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K061805

B. Purpose for Submission:
New assay

C. Measurand:
Lupus Anticoagulant

D. Type of Test:
Clotting

E. Applicant:
Diagnostica Stago

F. Proprietary and Established Names:
Staclot® DRVV Screen
Staclot® DRVV Confirm

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8950
2. Classification:
Class I
3. Product code:
GIR
4. Panel:

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81 Hematology

H. Intended Use:

1. Intended use(s):
The STA®-Staclot® dRVV Screen and Confirm are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell’s viper venom method.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:
Analyzers of the STA® line

I. Device Description:
The STA®-Staclot® dRVV Screen and Confirm assay Kit consists of freeze-dried Russell’s viper venom, phospholipids, calcium and heparin inhibitor (UHF). The STA®-Staclot® dRVV Screen is available in 2ml and 5 ml vials. The STA®-Staclot® dRVV Confirm is available in 2 ml vials.

J. Substantial Equivalence Information:

1. Predicate device name(s):
HemosIL LAC Screen and Confirm

2. Predicate 510(k) number(s):
K990302

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Detection of lupus anticoagulant in plasma by the dilute Russell’s viper venom method | Same |
| Sample Requirements | Citrated plasma | same |
| Storage requirement | 2-8 °C | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Reconstituted reagent stability | 72 hours | 48 hours |

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

## L. Test Principle:

Lupus anticoagulants are antibodies directed against phospholipid/protein complexes.

Staclot® dRVV Screen test is performed with a low phospholipids concentration reagent to screen samples. If lupus anticoagulants are present, the clotting time will be prolonged.

The Staclot® dRVV Confirm Reagent contains a higher phospholipids concentration to neutralize the LA present in the plasma to be tested. The clotting time obtained with the Staclot® dRVV Confirm Reagent will be shorter than the one observed with the Staclot® dRVV Screen reagent.

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

1. Analytical performance:

a. Precision/Reproducibility:

3 lots of Staclot® dRVV Screen and Confirm were used to determine within-run precision using LA positive and negative control plasmas. Each control was assayed 21 times on each lot. A CV of less than 1.0% was obtained for all lots.

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Inter-assay precision was assessed using lyophilized positive and negative LA samples on 1 lot of Staclot® dRVV Screen and Confirm. Positive and negative samples were assayed on the Staclot® dRVV Screen, and a positive sample was assayed on the Staclot® dRVV Confirm. Samples were assayed in 10 runs over 6 days. CV’s ≤ 4.1% was obtained for the Screen and Confirm reagents.

b. Linearity/assay reportable range:

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Stability data supported the reagent shelf life.

d. Detection limit:

e. Analytical specificity:

Samples from patients on heparin may give a falsely elevated clotting time using the Staclot® dRVV Screen and Confirm assays. The Staclot® dRVV Screen and Confirm Assay contains a heparin inhibitor that will neutralize the effects of heparin up to 0.8 IU/mL. To verify this claim a normal plasma pool and a LA positive plasma were spiked with known quantities of UF. The plasmas were then tested with three lots of Staclot® dRVV Screen and Confirm reagents. No significant difference was seen in the Screen, Confirm, and Normalized ratios up to 0.8 IU/mL.

To assess the effect of LMWH on the Staclot® dRVV Screen and Confirm assays, a normal plasma pool and a LA positive plasma were spiked with known quantities of Fragmin. The plasmas were then tested with three lots of Staclot® dRVV Screen and Confirm reagents. No significant difference was seen in the Screen, Confirm, and Normalized ratios up to 0.8 anti-Xa IU/mL fragmin.

f. Assay cut-off:

2. Comparison studies:

a. Method comparison with predicate device:

The device was compared to the predicate at a 2 site study. At site one samples were collected from several hospitals in France, and assayed at Diagnostica Stago. Site 2 testing was performed at a hospital reference

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laboratory in Canada. Results demonstrated 92% agreement with the predicate device.

b. Matrix comparison:

3. Clinical studies:

a. Clinical Sensitivity:

b. Clinical specificity:

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

5. Expected values/Reference range:

27 normal plasmas were tested with the Staclot® dRVV Screen and Confirm assays. A normal reference sample was also tested with each batch of test plasmas. Testing was performed over multiple days on the STA-R. The mean Staclot Screen and Confirm ratio was 1.04 and 1.08.

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.