ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS

K973196 · Zeus Scientific, Inc. · MID · Oct 29, 1997 · Immunology

Device Facts

• Record ID: K973196
• Device Name: ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
• Applicant: Zeus Scientific, Inc.
• Product Code: MID · Immunology
• Decision Date: Oct 29, 1997
• 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. Cardiolipin IgA ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Device Story

In vitro diagnostic ELISA test system; measures circulating IgA autoantibodies to cardiolipin in human serum. Used in clinical laboratory settings by trained laboratory personnel. Input: patient serum sample. Process: enzyme-linked immunosorbent assay (ELISA) methodology. Output: semiquantitative measurement of IgA autoantibodies. Results assist clinicians in diagnosing conditions associated with antiphospholipid syndrome, including recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Provides diagnostic support for patient management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) test system for semiquantitative measurement of IgA autoantibodies. In vitro diagnostic reagent kit.

Indications for Use

Indicated for the semiquantitative 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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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

. . . . . .

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

OCT 2 9 1997

K973196 Re: Anti-Cardiolipin IgA ELISA Reagents Trade Name: Requlatory Class: II Product Code: MID Dated: August 22, 1997 Received: August 26, 1997

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 requlations 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 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 Putman

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): K973196

Device Name: Zeus Scientific Inc. Anti-Cardiolipin IgA Ecesa Reagents.

Indications For Use:

## Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973196 |

| Prescription Use (Per 21 CFR 801.109) | |
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| Over-The-Counter Use (Optional Format 1-2-96) | |
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