(133 days)
The Wako Total Ketone Body Calibrators are intended to be used with the Wako Autokit Total Ketone Body products and instruments to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-hydroxybutyrate in human serum or plasma.
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This document is a 510(k) clearance letter from the FDA for Wako Total Ketone Body Calibrators. It does not contain a study or acceptance criteria in the way typically found for AI/ML-based diagnostic devices.
The information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) are all related to the validation of a diagnostic device based on an algorithm or AI. This document, however, describes a calibrator, which is a device used to set points of reference for an in vitro diagnostic test kit (the Wako Autokit Total Ketone Body test).
Therefore, I cannot provide the requested information from this document. The FDA approval here is for a calibrator, not a diagnostic algorithm.
To clarify, a calibrator's "performance" would typically be evaluated based on its accuracy, precision, and stability in providing known concentrations of the analyte (ketone bodies) within a specific range, to ensure the associated diagnostic test kit can be correctly 'calibrated'. The criteria and studies for a calibrator are very different from those for an AI-powered diagnostic tool.
§ 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.