(57 days)
The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.
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This document is a marketing authorization letter from the FDA, it does not contain information about the acceptance criteria and study details. It permits the marketing of "Drugs of Abuse Urine Calibrators and Controls" and states its intended use, but does not provide any performance data, study design, or ground truth establishment methods. Therefore, I cannot extract the requested information from this document.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.