(40 days)
quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of theumatoid arthritis.
Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis.
Here's a breakdown of the acceptance criteria and study information for the quantex RF plus device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison/Correlation | Substantial equivalence in performance to the predicate device, implying strong correlation between the new device and the predicate device across different automated instrumentation with extended analysis range (0-200 IU/mL). (Implied: High correlation coefficient (r)) | Monarch: r = 0.992 (with n=152 samples) |
| Hitachi: r = 0.995 (with n=175 samples) | ||
| Cobas Mira: r = 0.990 (with n=261 samples) | ||
| Precision (Within Run CV) | Within run coefficient of variation (CVs) |
§ 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).