(91 days)
The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Lit-heparin, Na+citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgC class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.
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This document is a 510(k) clearance letter from the FDA for an In Vitro Diagnostic (IVD) device, specifically an ELISA test for anti-tissue transglutaminase antibodies. These types of regulatory documents typically do not contain the detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would be found in a clinical trial report or a submission summary.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination of substantial equivalence relies on the manufacturer providing adequate data, but the letter itself does not present that data in a public-facing way.
Therefore, I cannot extract the requested information from the provided text. The document is an FDA clearance letter and not a detailed clinical study report.
§ 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).