(105 days)
Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.
Not Found
This an in-vitro diagnostic device, and the provided text does not contain the detailed study information typically associated with the acceptance criteria and performance evaluation of AI/ML-driven devices. The document is a 510(k) clearance letter for a C-reactive protein (CRP) test system, indicating it's a traditional medical device rather than an AI/ML product.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria using AI/ML methodologies.
§ 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).