(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.
§ 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).