(228 days)
The QUANTA Lite ™ Toxoplasma IgG ELISA System is designed for the semiine Quantitative determination of IgG antibodies to Toxoplasma gondii in human qualiticative accemination on as a be used to evaluate serologic evidence Serma. The esse off our and for in vitro diagnostic use. It can be used for prenatal screening for T. gondii IgG.
Not Found
The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Toxoplasma IgG ELISA Test Kit," indicating that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies.
§ 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).