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

Intended 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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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 Drive<br>Parsippany, NJ 07054 |
| Contact Person: | Bob Wallish |
| Phone #: | 800-222-2624, x 2044 |
| Fax #: | 973-631-1618 |
| E-mail: | [e-mail] |
| 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

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.

## e) Technological Characteristic Summary

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. A comparison of the two kits is summarized in the following table.

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 and<br>Confirm | LAC Screen and LAC Confirm |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The STA®-Staclot® dRVV Screen<br>and STA®-Staclot® dRVV Confirm<br>kits are intended for the detection of<br>lupus anticoagulants (LA) in plasma<br>by the dilute Russell's viper venom<br>method performed with analyzers of<br>the STA® line suitable to these<br>reagents. | Diluted Russell's Viper Venom Test<br>(DRVVT) reagents for the detection of<br>lupus anticoagulants (a type of<br>phospholipid interfering antibody) in<br>human citrated plasma on the IL<br>Coagulation systems.<br>LAC Screen: Simplified DRVV<br>reagent to screen for the presence of<br>Lupus Anticoagulants<br>LAC Confirm: Phospholipid rich<br>DRVV reagent to confirm the<br>presence of Lupus Anticoagulants. |
| Reagent Composition | Russell's viper venom,<br>phospholipids, calcium and heparin<br>inhibitor. | Russell's viper venom, phospholipids,<br>calcium, heparin inhibitor, buffers,<br>stabilizers, dyes and preservative. |
| Reagent Stability | Intact vials at 2-8 °C: until expiration<br>Reconstituted on analyzer (15-20°C):<br>72 hours | Intact vials at 2-8 °C: until expiration<br>Reconstituted:<br>2-8 °C:48 hr<br>15-25 °C: 24 hr<br>-20 °C:1 mo |
| Test Sample | Citrated plasma | Citrated plasma |
| Expected Values | Normalized Ratio: <= 1.20 | Normalized LAC Ratio: 0.8-1.2 |
| Intra-Assay<br>Reproducibility | Normal: CV%=0.5<br>LA Positive: CV%= 0.4 | Normal: CV%=1.16<br>LA Positive CV%= 0.84 |
| Inter-Assay<br>Reproducibility | Normal: CV%=2.2<br>LA Positive : CV%= 3.0 | Normal: CV%=1.70<br>LA 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 [phone]. 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 [phone] or [phone] 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:

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.

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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