(149 days)
This indirect immunofluorescence kit, with ethanol and formalin fixed human neutrophils as a substrate, is for the screening and titration of circulating anti-neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers for the diagnosis and other systemic vasculitides.
Not Found
This appears to be a 510(k) clearance letter from the FDA. It indicates that a device, the "ANCA Combi Diagnostic Test Kit," has been found substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, or adjudication methods), or any multi-reader multi-case (MRMC) or standalone studies.
The letter is a regulatory document confirming clearance, not a summary of the test data or clinical study results that led to that clearance.
Therefore, I cannot provide the requested information from the given 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).