(33 days)
The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Not Found
This looks like an FDA clearance letter for an in-vitro diagnostic device, specifically quality control materials. It does not contain the kind of detailed study information you're asking for regarding acceptance criteria, device performance, sample sizes, expert ground truth, or AI-related metrics.
The document primarily states that the device, CEDIA® Cyclosporine Plus High Range Controls 4 and 5, has been found substantially equivalent to legally marketed predicate devices. It confirms the device's classification and its intended use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Therefore, I cannot extract the information you've requested from this document. The typical FDA 510(k) summary (or the full submission if it were available) would contain the details of the studies performed to demonstrate substantial equivalence, including performance data.
§ 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.