(69 days)
Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Calibrator for automated systems (C.f.a.s.) Proteins
The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Calibrator for automated systems (C.f.a.s.) Proteins." This document is a regulatory approval letter and does not contain the detailed information about acceptance criteria or a study that proves the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include the results of performance studies, sample sizes, expert qualifications, or ground truth establishment.
§ 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.