(49 days)
The Multi-Chem Calibrator B is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Glucose, Uric Acid and Urea N in human serum.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Multi-Chem Calibrator B," and it only lists the device name, regulation number, product code, and its intended use. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about Multi-Reader Multi-Case (MRMC) studies or effect sizes.
- Results from standalone (algorithm only) performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document confirms substantial equivalence, which is a regulatory decision, not a detailed performance 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.