(32 days)
The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
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This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix NiCosure Cotinine Urine Control." It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. This letter signifies that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which is a regulatory decision and not a performance study report.
Therefore, I cannot provide the requested information from the given text.
To answer your specific questions, I would need a document that describes the performance characteristics and validation study of the "Quantimetrix NiCosure Cotinine Urine Control," not just its regulatory clearance.
§ 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.