(28 days)
Elecsys FSH II CalSet is used for calibrating the quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems.
Roche Diagnostics Elecsys FSH II CalSet consists of lyophilized human serum with added human FSH in two concentration ranges.
The provided text is a 510(k) summary for the "Elecsys FSH II CalSet" and does not contain information on acceptance criteria or a study proving the device meets those criteria. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
Therefore, I cannot extract the requested information from the given document. The document describes the device, its intended use, and compares it to a predicate device to claim substantial equivalence, which is the primary purpose of a 510(k) submission. It does not include details on formal acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance assessments.
§ 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.