(85 days)
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's rheumatoid factor testing methodologies.
Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.
This is a 510(k) summary for a medical device called "Liquichek Rheumatoid Factor Control" and concerns a quality control serum, not an AI/ML powered device. As such, the information requested in your prompt (acceptance criteria, study details like sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission for a quality control product.
The document discusses the intended use, device description, and a comparison of technological characteristics to a previously cleared device for establishing substantial equivalence. It does not contain any performance data against acceptance criteria in the way you've described for an AI/ML diagnostic or prognostic device.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).