(181 days)
NycoCard® CRP Test system is an in vitro diagnostic device for the quantification of Creactive protein (CRP) in human serum, plasma, and whole blood by a solid phase, sandwich-format, immunometric assay. The measurement of CRP aids in evaluation of sandwish inflammatory process induced by infectious microbial agents or by noninfectious inflammatory stimuli.
Not Found
This looks like a 510(k) clearance letter for the NycoCard® CRP device, which is an in vitro diagnostic device. This type of document typically declares the device substantially equivalent to a predicate device and allows it to be marketed. However, it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria, nor does it typically discuss AI or ground truth in the context of device performance studies.
The information provided is primarily regulatory in nature (device name, regulation number, product code, substantial equivalence determination). There is no mention of specific performance metrics, sample sizes for studies, expert involvement, adjudication methods, or AI comparative effectiveness studies.
Therefore, I cannot extract the requested information from the provided text.
§ 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).