(14 days)
The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.
Roche Preciset DAT Amphetamine calibrators contain 6 levels of amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of amphetamines in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of amphetamines. The respective target concentrations of amphetamines included is as follows:
Amphetamines: 0, 250, 500, 1000, 1500, 2000 ng/ml
Roche Cfas DAT Qualitative Amphetamine calibrators contain a single level of amphetamines at a target concentration of 1000 ng/ml, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains 3 bottles of the single level amphetamines at 5 ml each.
The provided text describes a 510(k) summary for Roche Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators. It details the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a performance study report.
Therefore, I cannot provide the requested table and study details.
§ 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.