BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT

K981030 · The Binding Site, Ltd. · MOB · Jul 20, 1998 · Immunology

Device Facts

• Record ID: K981030
• Device Name: BINDAZYME ANTI-MPO 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 intended for the in-vitro measurement of antibodies to myeloperoxidase (MPO) present in serum, as an aid in the diagnosis of certain types of autoimmune vasculitis, including glomerulonephritis, in conjunction with other clinical findings.

Device Story

The Bindazyme Anti-MPO Enzyme Immunoassay Kit is an in-vitro diagnostic test used to detect anti-myeloperoxidase antibodies in patient serum. The device operates as an enzyme-linked immunosorbent assay (ELISA). It is intended for use in clinical laboratory settings by trained laboratory personnel. The assay provides a quantitative or semi-quantitative measurement of MPO antibodies, which clinicians use alongside other clinical findings to support the diagnosis of autoimmune vasculitis and glomerulonephritis. The test results assist in the diagnostic process for patients presenting with symptoms suggestive of these conditions.

Clinical Evidence

No clinical data provided in the document; the document is a 510(k) clearance letter.

Technological Characteristics

Enzyme Immunoassay (ELISA) kit for the detection of anti-MPO antibodies in serum. The device is an in-vitro diagnostic reagent system.

Indications for Use

Indicated for the in-vitro measurement of anti-myeloperoxidase (MPO) antibodies in human serum to aid in the diagnosis of autoimmune vasculitis, including glomerulonephritis, 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

K981030 Re : Bindazyme Anti-MPO Enzyme Immunoassay Kit Trade Name: 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, qood 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 (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 Regulation (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 Reqister. 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.gov/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-MPO Enzyme Immunoassay Kit Device Name:

Indications for Use: This assay is intended for the in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings.

Peter J. Minium

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number

Prescription Use