(30 days)
Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of available analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.
Liquid Saliva/Urine Drugs of Abuse Control
I am sorry but this document does not contain the information requested. This document is a 510k clearance letter from the FDA to Clinical Controls for their Liquid Saliva/Urine Drugs of Abuse Control device. It confirms that the device is substantially equivalent to previously marketed devices and can be legally marketed.
The document does not provide any details about:
- Acceptance criteria for device performance.
- The study that proves the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for any studies.
- Information on MRMC studies, standalone performance, or ground truth types.
- Details about training sets or how their ground truth was established.
Therefore, I cannot fulfill your request based on the provided 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.