(32 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 IgA ELISA Test System is an automated or manually operated 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.
Automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin.
This document is a marketing approval for a device, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and associated study results. The provided text is a 510(k) clearance letter from the FDA for a device called "Aptus (Automated) Application for the Anti-Cardiolipin IgA ELISA Test System." It confirms that the device is substantially equivalent to legally marketed predicate devices.
Missing Information:
The document primarily focuses on regulatory approval and device classification. It does not contain any information regarding:
- A table of acceptance criteria and reported device performance metrics.
- Sample sizes used for test sets or their data provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth of test sets.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be extracted (though limited to general device information):
- Device Name: Aptus (Automated) Application for the Anti-Cardiolipin IgA ELISA Test System
- Regulatory Class: II
- Product Code: MID
- 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 automated or manually operated 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.
- Type of Device: Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative measurement of IgA autoantibodies to cardiolipin.
- Operation: Automated or manually operated.
To provide the requested information, a different type of document, such as a clinical study report or a validation report submitted as part of the 510(k) application, would be necessary.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEC 22 1998 Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re : K984173 Aptus (Automated) Application for the Anti-Trade Name: Cardiolipin IgA ELISA Test System Regulatory Class:II Product Code: MID November 18, 1998 Dated: Received: November 20, 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 leqally 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 Requlations, 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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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 (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 Sutman
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): ¡ 984173
Device Name: Aptus (automated) Application for the Anti-Cardiolipin IgA 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 IgA ELISA Test System is an automated or manually operated 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.
Peter E. Malins
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 V
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).