(123 days)
This assay is intended for the in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings.
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I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Bindazyme Anti-MPO Enzyme Immunoassay Kit". It states that the device is substantially equivalent to a predicate device and can be marketed. It does not include details about specific acceptance criteria or an efficacy study.
§ 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).