(27 days)
The Olympus Serum Protein Multicalibrator is designed for use in Olympus automated clinical chemistry analyzers for IgG, IgA, IgM, C3, C4, Transferrin, Ferritin, CRP, and ASO determinations.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Olympus Serum Protein Multi Calibrator." This letter generally does not contain detailed information about acceptance criteria or specific study results for device performance as you've requested.
The 510(k) process primarily demonstrates substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While the submission for a 510(k) would include performance data to support substantial equivalence, the clearance letter itself is a summary of the FDA's decision and does not elaborate on the specific studies.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.
To obtain this information, you would typically need to consult the original 510(k) submission documentation, which is often much more extensive than the clearance letter. This documentation would contain the test plans, results, and analyses that supported the claims of the device manufacturer and led to the FDA's clearance.
§ 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.