(177 days)
This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test 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.
This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
Not Found
I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and study details. The document is a 510(k) clearance letter from the FDA for two ELISA test kits (EUROIMMUN anti-Proteinase 3 (PR3) ELISA IgG and EUROIMMUN anti-Myeloperoxidase (MPO) ELISA IgG).
It confirms the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not include:
- A table of acceptance criteria and reported device performance. This kind of data is typically found in the 510(k) submission itself, not the clearance letter.
- Sample size and data provenance for the test set.
- Details on experts used for ground truth or adjudication methods.
- Information about multi-reader multi-case studies or standalone algorithm performance. This is an IVD device, not an AI-powered diagnostic device, so these specific details are not applicable.
- Type of ground truth used. While the indications mention "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth for the study is not described.
- Sample size for the training set or how its ground truth was established. This refers to machine learning models, which are not relevant for this type of ELISA test kit.
To obtain the information you're looking for, you would generally need to review the full 510(k) submission document, which often includes detailed study designs, performance data, and other technical information. The clearance letter acts as the FDA's confirmation of marketability based on that submission.
§ 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).