(76 days)
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge: The CardioPhase® hsCRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. High sensitivity CRP measurements may be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, 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.
Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the high sensitivity C-reactive protein (hsCRP) method on the Dimension Vista™ System.
Dimension Vista™ high sensitivity CRP Control L and Dimension Vista™ high sensitivity CRP Control H: hsCRP Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge: Dimension Vista - Ourdror naoo nal antibodies specific to human CRP are Polystylene particles couled with samples containing CRP. These aggregates scater a beam aggregated when mixed with our prob seintersity of the scattered light is proportional to of light passed through the sample. The sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).
Dimension Vista™ high sensitivity CRP Control L and H: Dimension Vista – Migh ochoand H are liquid human serum based products containing C-reactive protein.
The provided text describes the 510(k) summary for the Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator, and Dimension Vista™ high sensitivity CRP Control L and H. It details the device, its intended use, and claims substantial equivalence to previously marketed devices. However, the document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested.
The "Device Performance Characteristics" section {2} mentions a "Method Comparison Study" that compared the new assay to a predicate device. It states, "The Dimension Vista™ CardioPhase® hsCRP assay was compared to the Dade Behring CardioPhase® hsCRP assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.169 to 8.922 mg/L. Regression analyses of these results yielded the following equations:" However, the actual regression equations, specific performance metrics (like accuracy, sensitivity, specificity, precision), and acceptance criteria for these metrics are missing from the provided text.
Therefore, I cannot provide the requested table or detailed information about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given document.
The document mainly focuses on the regulatory submission, product description, and intended use, rather than a detailed scientific study report with acceptance criteria and performance data.
§ 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).