(190 days)
Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Clearview™ IM". This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.
The letter is a regulatory approval document and not a scientific study report. It states that the device is "an immunoassay for the qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis."
Therefore, I cannot provide the requested information based on the text provided. To answer your questions, I would need a different type of document, such as a clinical study report, a scientific publication, or the device's 510(k) submission summary which often includes performance data.
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).