REAGENT, RUSSEL VIPER VENOM - LA SCREEN

K132130 · Dsrv, Inc. · GIR · Jan 10, 2014 · Hematology

Device Facts

• Record ID: K132130
• Device Name: REAGENT, RUSSEL VIPER VENOM - LA SCREEN
• Applicant: Dsrv, Inc.
• Product Code: GIR · Hematology
• Decision Date: Jan 10, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8950
• Device Class: Class 1

Intended Use

Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants. This product is for in-vitro diagnostic use only.

Device Story

Lupo-Test Reagent; in vitro diagnostic reagent. Modification involves transition from lyophilized format to frozen format stored at -80°C. Manufacturing and formulation processes remain identical to previously cleared version, excluding the removal of the reconstitution step. Used in clinical laboratory settings for diagnostic testing. Output provides diagnostic results based on reagent interaction with patient samples. Modification verified via FMEA per ISO 14971 to ensure performance characteristics remain equivalent to predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro diagnostic reagent; Dilute Russell Viper Venom Test (DRVVT) chemistry; frozen liquid format; intended for use in one-stage clotting assays.

Indications for Use

Indicated for in-vitro diagnostic screening of Lupus Anticoagulants (LA) in patients using one-stage clotting tests (DRVVT).

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or flowing water.

Public Health Service

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2014

DSRV, Inc. c/o Ms. Lawanda Washington 780 Park North Boulevard, Suite100 Clarkston. GA 30021

Re: k132130 Trade/Device Name: Frozen Format LA Screen Regulation Number: 21 CFR 864.8950 Regulation Name: Russell viper venom reagent Regulatory Class: I Product Code: GIR Dated: December 10, 2013 Received: December 11, 2013

Dear Ms. Washington:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lawanda Washington

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Maria M. Chan -S

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known): K132130

#### Device Name: Frozen Format LA Screen

Indications For Use:

#### IFU Frozen Format LA Screen

Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.

Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants.

This product is for in-vitro diagnostic use only.

Prescription Use
(Part 21 CFR 801 Subpart D) ✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

## Leonthena R. Carrington -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): K132130