(175 days)
The Euro-Diagnostica Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.
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This document is a 510(k) clearance letter for the Euro-Diagnostica Immunoscan PR3-ANCA Kit. It does not contain detailed information about the acceptance criteria or the study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information from the provided text.
The provided text is a regulatory clearance letter and does not contain the detailed study design or results used to establish performance or 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).