ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM

K971784 · Zeus Scientific, Inc. · MID · Jul 23, 1997 · Immunology

Device Facts

• Record ID: K971784
• Device Name: ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MID · Immunology
• Decision Date: Jul 23, 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 Detection of these autoantibodies may aid in the spontaneous abortions. diagnosis of such disorders. The Zeus Scientific, Inc. Cardiolipin IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Device Story

The Zeus Scientific Anti-Cardiolipin IgG/IgM ELISA Test System is an in vitro diagnostic assay used in clinical laboratories. It detects circulating IgG and IgM autoantibodies to cardiolipin in patient serum samples. The device utilizes an enzyme-linked immunosorbent assay (ELISA) principle, where patient samples are incubated in wells coated with cardiolipin antigen. After washing, enzyme-conjugated anti-human IgG/IgM is added, followed by a substrate to produce a colorimetric signal proportional to the concentration of autoantibodies present. Healthcare providers use the resulting semi-quantitative measurements to assist in diagnosing clinical conditions associated with antiphospholipid syndrome, such as recurrent thrombosis, thrombocytopenia, and spontaneous abortions. The test is intended for prescription use by trained laboratory personnel.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the established nature of the ELISA methodology for this analyte.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgG and IgM autoantibodies. Utilizes cardiolipin-coated microtiter plates, enzyme-conjugated secondary antibodies, and colorimetric substrate detection. Standalone in vitro diagnostic test system.

Indications for Use

Indicated for the semi-quantitative measurement of circulating IgG and IgM 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. P.O. Box 38 Raritan, New Jersey 08869

JUL 2 3 1997

Re: K971784 Zeus Scientific, Inc., Anti-Cardiolipin IgG/IgM Trade Name: ELISA Test System Regulatory Class: II Product Code: MID Dated: May 12, 1997 Received: May 14, 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, 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 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.

{1}------------------------------------------------

Page 2

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 requlation (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 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

{2}------------------------------------------------

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|--------------------------------------|
| 510(k) Number (if known): | K971784 |
| Device Name: | Anti-Cardiolipin IgG/IgM Test System |
| 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 IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Peter E. Mafin

(Division Sign-Off)
Division of Industrial Operations

Rev 07/18/97

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

ll l

(Optional Format 1-2-96)