(24 days)
The Zeus Scientfic, Inc. MPO ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to myeloperoxidase in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to MPO. Elevated antibody levels to MPO may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "The Aptus (Automated) Application of the MPO ELISA Test System." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the acceptance criteria, reported device performance, details of a study proving the device meets criteria, sample sizes, expert qualifications, adjudication methods, or information about training sets.
Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory approval letter.
§ 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).