(131 days)
Olympus RF Latex System Reagent for the quantitative determination of Rheumatoid Factor (RF) in human serum and plasma on OLYMPUS Analyzers. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
The Olympus RF Latex Calibrator is a liquid human serum based matrix calibrator intended to be used with the Olympus RF Latex reagent OSR61105 for the quantitative determination of Rheumatoid Factor (RF) on Olympus analyzers.
Not Found
The provided text describes a 510(k) premarket notification for the "Olympus RF Latex Reagent" and "Olympus RF Latex Calibrator". However, the document is a clearance letter from the FDA and the "Indications for Use" statements.
Crucially, the provided document does not contain any information about acceptance criteria or specific studies proving the device meets those criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given text. The text only confirms the FDA's "substantially equivalent" determination to legally marketed predicate devices, which is part of the 510(k) process but does not detail the specific performance studies conducted by the manufacturer.
§ 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).