(23 days)
Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.
The Tina-quant® Rheumatoid Factors II Test System is a particle enhanced immunoturbidimetric assay. Latex-bound heat inactivated IgG (antigen) reacts with the RF-antibodies in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
The provided text is a 510(k) summary for the Tina-quant® RF II Test System, a medical device for in vitro diagnostic use. It describes the device, its intended use, and claims substantial equivalence to a previously marketed device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt.
Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory submission, not a detailed study report.
§ 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).