(144 days)
This assay is designed for the in-vitro measurement of specific IgG autoantibodies aqainst tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
This assay is designed for the in-vitro measurement of specific IqA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.
Not Found
This document is a 510(k) premarket notification for two in-vitro diagnostic devices: "Bindazyme® Human IgG Anti-Tissue Transglutaminase Enzyme Immunoassay Kit" and "Bindazyme® Human IgA Anti-Tissue Transglutaminase Enzyme Immunoassay Kit". As such, it's a notification seeking regulatory clearance based on substantial equivalence to a predicate device, rather than a detailed study report proving performance against explicit acceptance criteria in the manner of a clinical trial for a novel device. The document does not contain the specific information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert-related details typically found in a clinical study report.
Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on the FDA's decision regarding substantial equivalence for marketing purposes.
§ 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).