(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.
§ 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).