(265 days)
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite Rheumatoid Factor Kit comprises the following reagents: Reaction Buffer, Latex Reagent, RF Controls (supplied at 2 levels, Low and High), and RF Calibrator.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, structured according to your requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Total Precision | %CV |
§ 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).