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 Description

The in vitro diagnostic device presented in this 510K submission, STA® -Staclote dRVV Screen and STA® -Staclot® dRVV Confirm, is substantially equivalent to the IL Test LAC Screen and Confirm manufactured by Instrumentation Laboratories.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The submission implicitly uses "percent agreement" with a predicate device as its primary acceptance criterion for demonstrating substantial equivalence.

Acceptance Criteria	Reported Device Performance
Percent Agreement with predicate device (LAC Screen and Confirm manufactured by Instrumentation Laboratories)	92%

2. Sample Size and Data Provenance

Sample Size for Test Set: 90 plasma samples.
Data Provenance: The plasmas were obtained from "patients with various clinical pathologies." The country of origin is not explicitly stated. The study appears to be retrospective, as samples from existing patients were collected and tested.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the summary. The study relies on agreement with a predicate device rather than an independently established expert ground truth for each sample being tested.

4. Adjudication Method

This information is not applicable/provided. The study focuses on agreement with a predicate device, not on adjudicating discrepancies between multiple readers or diagnostic methods for ground truth establishment.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. This study is an in vitro diagnostic device (reagent kit) and does not involve human readers interpreting results in the same way, for example, a medical imaging AI would. The comparison is between the new device's results and those of a predicate device.

6. Standalone Performance Study

A standalone performance study was implicitly done in the sense that the device was used independently to generate results. However, its effectiveness was measured by agreement with a predicate device, which inherently involves a comparison. If "standalone" refers to performance against an absolute gold standard established independently (e.g., pathology), that was not the primary focus or method of proving substantial equivalence in this submission. The "92% agreement" figure is the standalone device's performance relative to the predicate.

7. Type of Ground Truth Used

The ground truth for the study was established through the results obtained from a predicate device (IL Test LAC Screen and Confirm). The "ground truth" here is essentially the performance of the legally marketed predicate device.

8. Sample Size for Training Set

The sample size for a "training set" is not applicable/provided. This device is a reagent kit, not a machine learning algorithm that requires a distinct training phase on a dataset. The 90 plasma samples constitute the test set used for the substantial equivalence study.

9. How Ground Truth for Training Set Was Established

This information is not applicable as there is no training set mentioned in the context of a machine learning model.

Summary

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K04.1805

1) 510K Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K061805

DEC - 6 2006

a) Applicant Name and Address

Applicant:	Diagnostica Stago, Inc.
Address:	5 Century DriveParsippany, NJ 07054
Contact Person:	Bob Wallish
Phone #:	800-222-2624, x 2044
Fax #:	973-631-1618
E-mail:	Bob.Wallish@stago-us.com
Date of Preparation:	11/29/06

b) Device Name

Trade Name:	STA® Staclot® dRVVT Screen and Confirm
Common Name:	Dilute Russell's Viper Venom Kits
Classification Name:	RUSSELL VIPER VENOM REAGENT (21 cfr 864.8950) Product Code GIR

c) Predicate Device

LAC Screen and Confirm manufactured by Instrumentation Laboratories (K990302).

d) Intended Use/Device Description

e) Technological Characteristic Summary

Ninety plasmas obtained from patients with various clinical pathologies were tested with both kits at two sites. The percent agreement was 92%.

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Applicable Technology	STA® - Staclot® dRVV Screen andConfirm	LAC Screen and LAC Confirm
Intended Use	The STA®-Staclot® dRVV Screenand STA®-Staclot® dRVV Confirmkits are intended for the detection oflupus anticoagulants (LA) in plasmaby the dilute Russell's viper venommethod performed with analyzers ofthe STA® line suitable to thesereagents.	Diluted Russell's Viper Venom Test(DRVVT) reagents for the detection oflupus anticoagulants (a type ofphospholipid interfering antibody) inhuman citrated plasma on the ILCoagulation systems.LAC Screen: Simplified DRVVreagent to screen for the presence ofLupus AnticoagulantsLAC Confirm: Phospholipid richDRVV reagent to confirm thepresence of Lupus Anticoagulants.
Reagent Composition	Russell's viper venom,phospholipids, calcium and heparininhibitor.	Russell's viper venom, phospholipids,calcium, heparin inhibitor, buffers,stabilizers, dyes and preservative.
Reagent Stability	Intact vials at 2-8 °C: until expirationReconstituted on analyzer (15-20°C):72 hours	Intact vials at 2-8 °C: until expirationReconstituted:2-8 °C:48 hr15-25 °C: 24 hr-20 °C:1 mo
Test Sample	Citrated plasma	Citrated plasma
Expected Values	Normalized Ratio: <= 1.20	Normalized LAC Ratio: 0.8-1.2
Intra-AssayReproducibility	Normal: CV%=0.5LA Positive: CV%= 0.4	Normal: CV%=1.16LA Positive CV%= 0.84
Inter-AssayReproducibility	Normal: CV%=2.2LA Positive : CV%= 3.0	Normal: CV%=1.70LA Positive: CV%= 3.02

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Laura A. Worfolk, Ph.D. Acting Director of Quality Control and Regulatory Affairs Diagnostica Stago, Inc 5 Century Drive Parsippany, NJ 07054

DEC - 6 2006

Rc: K061805

Trade/Device Name: STA® STACLOT® dRVV Screen and Confirm Regulation Number: 21 CFR § 864.8950 Regulation Name: Russel viper venom reagent Regulatory Class: I Product Code: GIR Dated: October 25, 2006 Received: October 26, 2006

Dear Dr. Worfolk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: STA®-STACLOT® dRVV Screen and

STA®-STACLOT® dRVV Confirm

Indications for Use:

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO61804 510(k)________________________________________________________________________________________________________________________________________________________________________

Prescription Use (Part 21 CFR 801 Subpart D)

. . . . . . .

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 864.8950 Russell viper venom reagent.

(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).