(36 days)
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when mixed with samples containing CRP. The intensity of the scattered light in the nephelometer depends on the CRP content of the sample and therefore the CRP concentration can be determined versus dilutions of a standard of a known concentration. The method is standardized against the IFCC/BCR/CAP reference preparation (Lot No.91/0619 = CRM 470 = RPPHS 91/0619 [Lot 5]).
The provided text is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically the N High Sensitivity CRP assay. IVD devices, especially those for quantitative measurements like this, are typically evaluated differently from AI/ML-based diagnostic imaging devices. The document explicitly states: "All performance characteristics were previously established under 510(k) Premarket Notification K991385." This indicates that the current submission (K033908) is not for a new device requiring extensive new performance studies, but rather a modification to the intended use statement of an already cleared device.
Therefore, the provided text does not contain the detailed acceptance criteria or the study information in the format requested for an AI/ML-based medical device. It describes an updated intended use for a previously cleared immunlogical test system.
Consequently, I cannot fill out the requested table and answer the study-specific questions based on the provided text. The information requested (multi-reader multi-case studies, ground truth establishment, sample sizes for training/test sets for AI models, expert qualifications, adjudication methods) is not relevant or present in this 510(k) summary for an immunological assay.
§ 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).