(60 days)
For in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophe salicylate assays.
Not Found
This document is a 510(k) premarket notification from the FDA, approving a diagnostic control material. It does not contain the kind of detailed information (acceptance criteria, study design, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a publication describing the validation of a medical AI device.
Therefore, I cannot provide the requested information. This document is about the regulatory clearance of a quality control material for acetaminophen and salicylate assays, not a device that uses AI or requires extensive performance studies as described in your prompt.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.