FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

K062183 · The Binding Site, Ltd. · LRM · Nov 21, 2006 · Immunology

Device Facts

• Record ID: K062183
• Device Name: FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
• Applicant: The Binding Site, Ltd.
• Product Code: LRM · Immunology
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.

Device Story

FARRZYME is an enzyme immunoassay (EIA) kit for detecting high avidity IgG autoantibodies against dsDNA in human serum. Used in clinical laboratories by trained personnel to aid in diagnosing systemic lupus erythematosus (SLE). The assay measures antibody-antigen binding; results are interpreted by clinicians alongside other serological tests and patient clinical presentation to support SLE diagnosis.

Clinical Evidence

Performance evaluated using 252 samples (189 SLE, 28 healthy, 35 dsDNA positive). Comparison with BINDAZYME ELISA showed 85.3% overall agreement; comparison with Crithidia luciliae showed 87.3% overall agreement. Comparison with Farr RIA (n=166) showed 92.8% overall agreement (89.8% positive percent agreement). Analytical precision: intra-assay CV 2.2-5.4%, inter-assay CV 3.9-13.5%. Cut-off established at 30 IU/mL using 150 healthy donors. No interference observed from bilirubin, hemoglobin, chyle, or rheumatoid factor.

Technological Characteristics

Enzyme immunoassay (EIA) kit; utilizes specific antigen-antibody binding principles for detection of high avidity IgG autoantibodies against dsDNA in human serum samples.

Indications for Use

Indicated for the in-vitro measurement of high avidity IgG anti-dsDNA autoantibodies in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE).

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, Ltd. c/o Jay H. Geller, Attorney West Tower, Suite 4000 2425 W. Olympic Blvd Santa Monica, CA 90404

DEC 1 9 2006

Re: k062183 Trade/Device Name: FARRZYME Human High Avidity Anti-dsDNA Enzyme Immunoassay Kit Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LRM Dated: July 25, 2006 Received: July 31, 2006

Dear Mr. Geller:

This letter corrects our substantially equivalent letter of November 21, 2006.

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 (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, condons provision 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 additional controls. Existing major regulations affecting your device can be may of able 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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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This letter will allow you to continue 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/dsma/dsmamain.html

Sincerely yours,

Robert Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices 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): k062183

Device Name: The Binding Site FARRZYME Human High Avidity anti-dsDNA Enzyme Immunoassay Kit

Indications For Use:

This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mana M Chan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

**510(k)** /K062183

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