(60 days)
The Toxoplasma IgM ELISA test system provides a means for the manual and/or automated (Aptus), presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum and for the presumptive diagnosos of acute, recent, or reactive infection. To adequately assess the patient's serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. The assay's performance has not been established for screening of prenatal women or newborns.
Not Found
The provided document is a 510(k) premarket notification approval letter for "The Aptus (automated) Application for the Toxoplasma IgM ELISA Test System." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to fill out the requested table and answer the specific questions about the device's performance, sample sizes, ground truth establishment, or multi-reader studies. The document is an administrative approval letter, not a scientific study report.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, the actual 510(k) submission (which would contain the performance studies) would need to be reviewed.
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).