(147 days)
The Rheumacol RF Test is a rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor (RF) in serum. This test is used as an aid in the diagnosis of rheumatoid arthritis. This test is "For Professional Use Only".
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The provided text is a 510(k) clearance letter from the FDA for a device named "Rheumacol RF Test". This document confirms that the device has been found substantially equivalent to a legally marketed predicate device. However, it does not contain any information about the acceptance criteria, reported device performance, study design, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report or a 510(k) summary.
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need access to the actual 510(k) submission document (K972456 summary) which details the studies performed to demonstrate substantial equivalence. The provided document is only the FDA's clearance letter.
§ 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).