(85 days)
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
The Randox Laboratories Limited C-Reactive Protein Calibrators should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels.
The provided document is a 510(k) premarket notification letter from the FDA to Randox Laboratories Limited regarding their C-Reactive Protein Calibrator. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The letter is an administrative approval, confirming that the device can be marketed based on its substantial equivalence to existing products, but it does not detail the technical studies that would typically be performed to establish performance against acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text.
§ 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.