(32 days)
The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix Drug of Abuse Urine Screen Control." It is a control material used for monitoring the performance of drug of abuse screening methods.
Unfortunately, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It focuses on regulatory compliance and administrative details, not on a detailed scientific efficacy study report.
Therefore, I cannot provide the requested information based on the input text.
§ 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.