(50 days)
The Toxoplasma IgG ELISA test system provides a means for the manual and/or automated (Aptus), qualitative determination of IgG-class antibody to T. gondii in human serum. The test system is intended to be used to evaluate serologic evidence of previous infection with T. gondli, and is for in vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "The Aptus (automated) Application for the Toxoplasma IgG ELISA Test System". This document does not contain the acceptance criteria or a study proving the device meets the acceptance criteria. It is a regulatory approval letter based on substantial equivalence to a legally marketed predicate device, not a performance study report.
Therefore, I cannot provide the requested information from the provided text.
§ 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).