(81 days)
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a Multi-Analyze Chemistry Calibrator. This document approves the device based on its substantial equivalence to a legally marketed predicate device.
It is crucial to understand that this document does not contain information about the performance or acceptance criteria of a diagnostic imaging AI device. Instead, it concerns an in-vitro diagnostic (IVD) calibrator product. Therefore, the details requested in the prompt, such as "test set," "ground truth," "MRMC study," "human readers improve with AI," and "standalone algorithm performance," are not applicable to the content provided.
The document discusses regulatory approval for a calibrator, not a device that analyzes images or medical data for diagnosis using AI.
As such, I cannot extract the requested information as it is not present in the provided text.
§ 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.