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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. anti-Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin.

The provided text is a 510(k) premarket notification letter from the FDA regarding an Anti-Cardiolipin IgM ELISA Test System. It confirms that the device is substantially equivalent to a predicate device and outlines regulatory information for marketing.

However, the document does not contain any information regarding specific acceptance criteria for device performance, the study that proves its performance against such criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot fulfill your request for the detailed breakdown of the acceptance criteria and study that proves the device meets them based solely on the provided text. The document is a regulatory approval letter, not a performance study report.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the actual study report submitted with the 510(k).

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