(64 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. 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.
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.
The provided text is related to a 510(k) premarket notification for the Zeus Scientific Inc. Anti-Cardiolipin IgA ELISA Reagents. It primarily details the FDA's approval of the device and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide the requested information based on the input text.
§ 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).