(138 days)
The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.
enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum.
The provided text is a 510(k) premarket notification letter from the FDA regarding two ELISA test systems (TheraTest EL-tTG™ IgA/IgG and TheraTest EL-Glia™ IgA/IgG) for aiding in the diagnosis of celiac disease and dermatitis herpetiformis.
However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
The letter is a notification of substantial equivalence to predicate devices, allowing the manufacturer to market the device, subject to general controls. It does not include specific study results or performance data that would detail acceptance criteria and a study proving the device meets them.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, or in accompanying performance data summaries, which are not part of this letter.
§ 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).