(42 days)
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids. Drug concentrations are determined using GC/MS.
This document describes the Preciset® DAT Plus, a drug of abuse calibrator. It does not contain information about a device that uses AI or machine learning, nor does it detail a study with acceptance criteria and device performance in the context of such technology. Therefore, I cannot generate the requested table and study information.
The document primarily focuses on the 510(k) submission for the Preciset® DAT Plus calibrators, detailing its classification, intended use, and substantial equivalence to a predicate device. It briefly mentions "Performance Characteristics" related to stability studies but does not provide specific acceptance criteria or quantitative performance data.
§ 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.