(63 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Not Found
The provided text is a clearance letter from the FDA for the Autostat™I Rheumatoid Factor IgG ELISA device (K993304). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study that proves the device meets those criteria, based on the information provided. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework for its marketing.
To answer your request, I would need access to the original 510(k) submission document (K993304) itself, or a summary of its performance data.
§ 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).