(126 days)
An enzyme linked immunoassay (ELISA) for the detection and semiquantitation of IgA antibodies to human tissue transglutaminase, as an aid in diagnosing patients with Gluten Sensitive Enteropathy (celiac Disease and Dematitis herpetiformis)
Not Found
This document is a FDA 510(k) clearance letter for the ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgA ELISA device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval notice and does not detail the technical performance evaluation or validation study results.
§ 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).