BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT

K981029 · The Binding Site, Ltd. · MOB · Jul 20, 1998 · Immunology

Device Facts

• Record ID: K981029
• Device Name: BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
• Applicant: The Binding Site, Ltd.
• Product Code: MOB · Immunology
• Decision Date: Jul 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This assay is designed for the in-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis in conjunction with other clinical findings.

Device Story

The Bindazyme Anti-PR3 Enzyme Immunoassay Kit is an in-vitro diagnostic device used to detect IgG autoantibodies against proteinase 3 (PR3) in human serum samples. The assay functions as an aid in the clinical diagnosis of Wegener's granulomatosis and specific forms of autoimmune vasculitis. It is intended for use by laboratory professionals in a clinical setting. The test results are interpreted by clinicians alongside other clinical findings to support diagnostic decision-making. The device provides a quantitative or semi-quantitative measurement of autoantibody levels, assisting in the identification of autoimmune conditions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme Immunoassay (EIA) kit for the detection of IgG autoantibodies. The device is an in-vitro diagnostic test requiring human serum samples. Technical specifications and materials are not detailed in the provided text.

Indications for Use

Indicated for the in-vitro measurement of IgG autoantibodies against proteinase 3 (PR3) in human serum to aid in the diagnosis of Wegener's granulomatosis and autoimmune vasculitis, used in conjunction with other clinical findings.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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## JUL 201998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, LTD. c/o Jay H. Geller East Tower, Suite 600 2425 West Olymic Boulevard Santa Monica, CA 90404

K981029 Re :

Trade Name: Bindazyme Anti-PR3 Enzyme Immunoassay Kit Requlatory Class: II Product Code: MOB Dated: June 11, 1998 Received: June 15, 1998

Dear Mr. Geller:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and * advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

## Anti-PR3 Enzyme Immunoassay Kit Device Name:

This assay is designed for the in-vitro Indications for Use: masourement of specific IgG autoantibodies against proteinase 3
(PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis in conjunction with other clinical findings.

Ceta E. Madim

(Division Si 510

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