(69 days)
Mult-Analyte Serum Calibrator is used for the calibration of clinical chemistry assays. The material is well suited for automated analyzers.
Not Found
This is a notification from the FDA regarding the 510(k) premarket notification for the RAICHEM® Multi-Analyte Calibrator. The document states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
The document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.
§ 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.