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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 IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

The Zeus Scientific, Inc. Cardiolipin IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin.

The provided text is related to a 510(k) clearance letter for a medical device called the "Anti-Cardiolipin IgG/IgM Test System." This document grants market clearance based on substantial equivalence to a predicate device and outlines the intended use. However, it does not include the detailed study results, acceptance criteria, or performance data that would typically be required to answer your specific questions about device performance and validation.

Therefore, I cannot provide the information requested in your prompt based on the provided text. The document is an FDA clearance letter, not a technical report detailing the device's performance study.

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