(292 days)
Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.
Not Found
I am sorry, but the provided text is a cover letter from the FDA regarding a 510(k) premarket notification for an in vitro diagnostic device (ImmuLisa Celiac TtG rHuman Tissue Transglutaminase Antibody ELISAs).
While it mentions the device, its intended use, and substantial equivalence to a predicate device, it does NOT contain any information about:
- Acceptance criteria or reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter, not a scientific study report or a summary of performance data. Therefore, I cannot extract the requested information from the provided text.
§ 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).