(68 days)
semiquantitative enzyme linked immunoassay for detecting IgM at class autoantibody to for glycoprotein I (Ag GPT) for use as an aid certain autoimmune disease thrombotic diagnosis of " the in in the "diagnobis" of "cercain" addemmic lupus erythematosus (SLE) or other lupus-like disorders.
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I am sorry. I cannot provide information on the acceptance criteria and study as the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain details about specific acceptance criteria or a study proving the device meets them. It primarily states that the device is substantially equivalent to a predicate device and can be marketed.
§ 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).