Search Results

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 automated or manually operated 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.

Automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin.

The provided text is a 510(k) clearance letter from the FDA for the "Aptus (Automated) Application for the Anti-Cardiolipin IgM ELISA Test System." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria, device performance, and ground truth establishment as would be found in a clinical trial report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within the provided FDA 510(k) clearance letter.

This type of document confirms that the device has met the regulatory requirements for market entry by demonstrating substantial equivalence to a previously cleared device. It does not typically include the raw data or detailed performance study results that would be used to prove the device meets specific acceptance criteria in the manner requested.

Ask a specific question about this device