(18 days)
The Zeus Scientific, Inc. ANCA Screen ELISA test system is intended for the qualitative detection of IgGclass antibody to myeloperoxidase and/or proteinase-3 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 anti-neutrophil cytoplasmic antibodies (ANCA) to MPO and/or PR-3 ANCA may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.
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This document is a 510(k) clearance letter from the FDA for a medical device called "The Aptus (automated) Application of the ANCA Screen ELISA test system." It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses the regulatory class, product code, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
To answer your request, I would need a document that describes the actual performance study and its results, along with the predetermined acceptance criteria.
§ 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).