(50 days)
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.
Not Found
This document is a 510(k) clearance letter for the ImmuLisa™ Anti-tissue Transglutaminase (tTG) Antibody Test. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on its substantial equivalence to an existing predicate device, not through a study demonstrating it meets specific acceptance criteria.
Therefore, I cannot provide the requested information from this document.
§ 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).