(180 days)
The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.
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I am sorry, but the provided text is an FDA 510(k) clearance letter and does not contain the specific information requested regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document primarily focuses on the regulatory clearance of the QUANTA Plex™ Celiac IgA Profile and its indications for use, stating that it has been deemed "substantially equivalent" to legally marketed predicate devices.
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§ 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).