(99 days)
For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.
A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.
The provided text is a 510(k) premarket notification approval letter for a device called "CRP-ADVANCE." It describes the device's indications for use and general regulatory information but does not contain a study report or detailed acceptance criteria with performance results.
Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
§ 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).