(283 days)
The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrents, in patients with stable coronary disease or acute coronary syndrome.
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The provided text is a 510(k) Premarket Notification clearance letter for a device called "CRP Vario." This document primarily
confirms the FDA's determination of substantial equivalence for a medical device to
a legally marketed predicate device.
Crucially, this document focuses on regulatory clearance and does NOT contain the detailed study information required to answer the
questions about acceptance criteria and device performance.
Specifically, the document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- The "Indications for Use" section describes what the device is intended for (quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma, and its use as an aid in identification of individuals at risk for cardiovascular disease).
To answer your questions about the acceptance criteria and the study that proves the device meets them, one would typically
need access to the underlying 510(k) submission document itself or efficacy study reports, which are not part of this
publicly available clearance letter.
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, training set size, or how ground truth was established.
- Details about expert involvement (number, qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
§ 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).