ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

K983694 · The Binding Site, Ltd. · MID · Feb 5, 1999 · Immunology

Device Facts

• Record ID: K983694
• Device Name: ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
• Applicant: The Binding Site, Ltd.
• Product Code: MID · Immunology
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The in-vitro measurement of anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).

Device Story

The Bindazyme Anticardiolipin IgM EIA Kit is an enzyme immunoassay (EIA) used for the in-vitro measurement of anticardiolipin antibodies in human serum. The device is intended for use in clinical laboratory settings by trained laboratory personnel. It functions by detecting specific IgM antibodies associated with antiphospholipid syndrome (APS). The healthcare provider uses the quantitative or qualitative output to assist in the clinical diagnosis of APS. By identifying the presence of these antibodies, the device aids in the diagnostic process, allowing for appropriate clinical management of patients suspected of having the syndrome.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) kit for in-vitro diagnostic use. The device utilizes standard immunoassay principles for the detection of IgM antibodies in human serum samples.

Indications for Use

Indicated for the in-vitro measurement of anticardiolipin antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS).

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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Public Health Service

5 1999 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404

Re: K983694 Trade Name: Anticardiolipin IgM Screen EIA Kit Regulatory Class: II Product Code: MID Dated: January 12, 1999 Received: January 20, 1999

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 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). 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 (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 requirements, 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 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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BINDAZYME® Anticardiolipin IgM EIA Kit Device Name:

I dM Indications Use: The in-vitro measurement of for anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).

Peter E. Makem

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

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