(287 days)
The i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the "i-Chroma CRP Test". This document approves the device based on its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set size, or how its ground truth was established) from the provided text. The document is primarily an approval letter and does not delve into the technical details of the validation studies beyond stating that a review was conducted.
§ 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).