(13 days)
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 IgG ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
The Zeus Scientific, Inc. anti-Cardiolipin IgG ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin.
This document is a 510(k) premarket notification received by the FDA in 1998 for an anti-Cardiolipin IgG ELISA Test System. It is an approval letter, and thus does not contain the detailed study information required to answer the questions. The letter states that the device is substantially equivalent to legally marketed predicate devices but does not provide any performance data or study details.
Therefore, I cannot provide a response with the requested information based on the given input text.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 1998
Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876
K984347 Re: Aptus (Automated) Application for the Anti-Trade Name: Cardiolipin IgG ELISA Test System II Regulatory Class: Product Code: MID Dated: December 3, 1998 Received: December 4, 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 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 A substantially equivalent determination assumes compliance to 895. 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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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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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510(k) Number (if known): 长984 347
Aptus (automated) Application for the Anti-Cardiolipin IgG Device Name: ELISA Test System
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 IgG ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin. This test is for in vitro diagnostic use.
Peter E. Molson
al Laboratory Devi
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
(Optional Format 1-
2-96)
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).