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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 IgG ELISA Test System is an 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 enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) clearance letter for the "Zeus Scientific, Inc. anti-Cardiolipin IgG ELISA Test System" from 1998.

Therefore, I cannot extract the requested information like:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for the test set
• Number of experts and their qualifications for establishing ground truth
• Adjudication method
• Whether an MRMC study was done and its effect size
• Whether a standalone performance study was done
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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