ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM

K981020 · Zeus Scientific, Inc. · MID · May 18, 1998 · Immunology

Device Facts

• Record ID: K981020
• Device Name: ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MID · Immunology
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Device Story

Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System is an in vitro diagnostic device used in clinical laboratories. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgA autoantibodies to cardiolipin in patient serum samples. The assay provides semi-quantitative measurements, which clinicians use to assist in diagnosing conditions linked to phospholipid autoantibodies, such as recurrent thrombosis, thrombocytopenia, and spontaneous abortions. The test is intended for prescription use by healthcare professionals.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on regulatory classification and intended use.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative measurement of IgA autoantibodies. In vitro diagnostic device.

Indications for Use

Indicated for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin in human serum to aid in the diagnosis of disorders associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions.

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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Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

Re: K981020 The Zeus Scientific, Inc. Anti-Cardiolipin IgA Trade Name: ELISA Test System Requlatory Class: II Product Code: MID Dated: March 15, 1998 Received: March 19, 1998

Dear Mr. Kopnitsky:

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, 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 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 Requlations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. ್ದರಿ 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 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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510(k) Number (if known): 198/020

The Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System Device Name:

Indications for Use:

Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K981020 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use |
|----------------------|-----------------------------------------|----|--------------------------|
| (Per 21 CFR 801,109) | | | (Optional Format 1-2-96) |