(161 days)
The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.
The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Binding Site Optilite C-Reactive Protein Reagent, Calibrator, and Controls have several performance characteristics, and the report details the studies conducted to verify these characteristics against pre-defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Total precision (%CV |
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).