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This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use,

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The provided text is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the EBV-VCA IgG ELISA Test System." This document grants market clearance based on substantial equivalence to a predicate device.

Crucially, this document does not contain details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment for the device's performance.

The letter focuses on regulatory approval and mentions that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on comparisons to existing, approved products. However, the specifics of those comparisons or the performance data itself are not present in this document.

Therefore, I cannot fulfill your request for the detailed information as the source text does not provide it. The information requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) would typically be found in the 510(k) submission itself, not in the clearance letter.

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