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The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain the detailed information necessary to complete the requested table and study description. The letter states that the device is substantially equivalent to a legally marketed predicate device but does not provide specific acceptance criteria or the study details that prove the device meets these criteria. Such information is typically found in the 510(k) summary or the full submission, which are often available separately.

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