(71 days)
The anti-PR3 indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Orgentec Anti-PR3 (C-ANCA) ELISA" device. This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed studies on acceptance criteria for device performance.
Therefore, the document does not contain the specific information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
- The type of ground truth used for test sets.
- Sample size for training sets or how ground truth for training sets was established.
The document states the device is "designed for the semi-quantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis." This is the intended use, but not detailed performance criteria.
To obtain the information requested, one would need to refer to the original 510(k) submission (K974702) by American Laboratory Products Company, which would contain the performance data and study details supporting the claims for substantial equivalence. The clearance letter itself only confirms that the FDA found the device substantially equivalent based on the submitted information.
§ 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).