(27 days)
The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "NycoCard® CRP Control" device. It is a control material used to monitor the precision and accuracy of C-reactive protein (CRP) assays, particularly with the NycoCard® CRP point-of-care test system.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.
Therefore, I cannot provide the requested information.
§ 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).