(71 days)
The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a device called "Orgentec Anti-MPO(P-ANCA) ELISA". It announces that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria, the study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The text only provides:
- Device Name: Orgentec Anti-MPO(P-ANCA) ELISA
- Intended Use: "The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis."
Therefore, based solely on the provided text, I cannot answer the requested questions regarding study details. This document is a regulatory approval letter, not a scientific study report.
§ 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).