(187 days)
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders
Not Found
I am sorry, but after reviewing the document, I could not find information regarding the specific acceptance criteria for the ImmuLisa Anti-Beta2 Glycoprotein I (ß2GP1) IgM ELISA device, nor details about a study that proves the device meets such criteria.
The document primarily consists of a 510(k) clearance letter from the FDA, confirming the device's substantial equivalence to a legally marketed predicate device. It also includes an "Indications For Use Statement." While it mentions the device is an "enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgM antibodies to B2-GP1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders," it does not provide performance metrics, study designs, sample sizes, or information about ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 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).