(41 days)
The CH50 Linearity Set is to be used with WAKO Autokit CH50 test for the estimation of the linearity limits of the reagent/instrument system for the CH50 analyte.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a device called "Wako CH50 Linearity Set." This document does not contain information about acceptance criteria or performance studies of the device against such criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study as would be described for a new, novel device.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) from this document. The document primarily confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally 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.