(84 days)
The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a Serum Protein Multicalibrator. This document is a regulatory approval letter and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided.
Therefore, I cannot extract the requested information. The document only states that the FDA has determined the device is "substantially equivalent" to previously marketed devices.
§ 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.