(42 days)
The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.
Not Found
This looks like a 510(k) summary for a medical device called "RDI hs CRP (C-reactive protein) Calibrator Set". The document provided is the FDA's clearance letter and the "Indications For Use" statement.
Unfortunately, this document does not contain the information requested regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study proving the device meets acceptance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria in the way a clinical trial or performance verification study would.
Therefore, I cannot populate the requested tables and information based solely on the provided text. To answer your questions, I would need a different type of document, such as a detailed performance study report or the technical documentation submitted with the 510(k) application.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.