(47 days)
The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.
Not Found
This is an FDA 510(k) clearance letter for a calibrator device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the "Olympus Lyophilized Chemistry Calibrator" to a legally marketed predicate device. It confirms the device's classification and allows it to proceed to market. The "Indications for Use Statement" clarifies that it's a two-level general-purpose chemistry calibrator for Olympus analyzers using Olympus methodologies.
In summary, none of the requested information regarding AI/ML device performance or studies is present in this 510(k) document.
§ 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.