(67 days)
An enzyme linked immunosorbant assay (ELISA) for the semiof autoantibodies to detection IgG quantitative myeloperoxidase(MPO). This test is to be used in conjunction with other clinical findings to aid in assessment of certain autoimmune vasculitides such as microscopic polyarteritis, and crescentic qlomerulonephritis.
Not Found
The provided text is an FDA 510(k) clearance letter for the QUANTA Lite™ MPO IgG device. It indicates that the device has been found substantially equivalent to a predicate device but does not contain the acceptance criteria or a study description as requested.
The letter is a regulatory document confirming clearance to market, not a scientific publication detailing performance studies. Therefore, I cannot extract the requested information from the provided text.
To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, a clinical study report, or a publication describing the device's performance.
§ 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).