(54 days)
This test system is designed for the manual or automated (Aptus), qualitative determination of IgG antibody to CMV in human serum. The test system is intended to be used to evaluate serologic evidence of previous infection with CMV and is for in vitro diagnostic use. The test is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the CMV IgG ELISA Test System." It primarily addresses the regulatory approval of the device and its intended use. It does not contain the detailed study results, acceptance criteria, or information about how ground truth was established, or sample sizes for testing or training sets.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, or ground truth establishment based on the provided text. The document is a regulatory approval, not a scientific study report.
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).