(71 days)
Linked Immunosorbant Assay (ELISA) for An the Enzyme nonquantitative detection of IgA antibodies to tissue transglutaminase (tTG) and gliadin in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.
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The provided text is a 510(k) approval letter from the FDA for the QUANTA Lite™ Celiac Screen ELISA. It primarily concerns regulatory approval and does not contain the detailed study information required to answer the requested questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone).
Therefore, I cannot provide the requested table and detailed information based solely on the provided text. The document confirms the device's substantial equivalence to a legally marketed predicate device and allows it to be marketed, but it does not include the underlying performance studies or their methodologies.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).