BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT

K030238 · The Binding Site, Ltd. · DBM · Mar 24, 2003 · Immunology

Device Facts

• Record ID: K030238
• Device Name: BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
• Applicant: The Binding Site, Ltd.
• Product Code: DBM · Immunology
• Decision Date: Mar 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5090
• Device Class: Class 2

Intended Use

This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.

Device Story

BINDAZYME Anti-Mitochondria M2 IgGAM EIA Kit is an in-vitro diagnostic assay used in clinical laboratory settings. It detects IgG, IgA, and IgM autoantibodies against mitochondria in human serum samples. The device utilizes an enzyme immunoassay (EIA) principle to measure these autoantibodies. Results are interpreted by healthcare professionals in conjunction with other clinical observations to aid in the diagnosis of primary biliary cirrhosis (PBC). The device provides a quantitative or semi-quantitative assessment of mitochondrial autoantibodies, assisting clinicians in confirming PBC diagnosis and managing patient care.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on performance characteristics typical of EIA-based immunological test systems.

Technological Characteristics

Enzyme immunoassay (EIA) for detection of IgG, IgA, and IgM autoantibodies. Class II device, product code DBM. Standard laboratory microplate-based format.

Indications for Use

Indicated for the in-vitro measurement of IgG, IgA, and IgM autoantibodies against mitochondria in human serum to aid in the diagnosis of primary biliary cirrhosis (PBC) in patients presenting with clinical symptoms.

Regulatory Classification

Identification

An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 2 4 2003

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

Re: k030238

> Trade/Device Name: BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit Regulation Number: 21 CFR 866.5090 Regulation Name: Anti-mitochondrial antibody immunological test system Regulatory Class: Class II Product Code: DBM Dated: January 20, 2003 Received: January 23, 2003

Dear Mr. Geller:

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).

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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.

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): KO30238

Device Name: BINDAZYME Anti - Mitochordria M2 Ig GAM EIA

Indications For Use:

## INDICATIONS FOR USE STATEMENT

BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit Device Name:

This assay is intended for the in-vitro Indications for Use: of specific IgG, IgA and IgM autoantibodies against measurement mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Reeves for J. Bautista

Division of Clinical Laboratory Devices

510(k) Number_1 CO >

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)