← Product Code [GIR](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR) · K061805

# STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805)

_Diagnostica Stago, Inc. · GIR · Dec 6, 2006 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K061805

## Device Facts

- **Applicant:** Diagnostica Stago, Inc.
- **Product Code:** [GIR](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR.md)
- **Decision Date:** Dec 6, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8950
- **Device Class:** Class 1
- **Review Panel:** Hematology

## 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.

## Regulatory 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](/device/K990302.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

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:

{1}

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:

{2}

|  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.

{3}

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

4

{4}

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.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K061805](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K061805)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com