(90 days)
evidence® Amphetamine Assay: The evidence® Amphetamine assays have been designed for use only on the evidence® analyser for qualitative detection of the amphetamine class of compounds in urine using a cut off concentration of 1000ng/ml in accordance with SAMHSA recommendations. Qualitative results obtained can be utilized in the diagnosis and treatment of amphetamine use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The evidence® Amphetamine assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
evidence® Drugs of Abuse Calibrators: The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine and methamphetamine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Not Found
The provided text describes an FDA 510(k) clearance for the "evidence® Amphetamine Assay and the evidence® Drugs of Abuse Calibrators." However, this document is a regulatory clearance letter and does not contain the detailed study information required to answer your questions about acceptance criteria and device performance studies.
Specifically, the letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It states the indications for use, regulatory classification, and advises on general controls and additional regulations. It does not include the results of performance studies, acceptance criteria, sample sizes, ground truth establishment, or details about expert involvement.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need access to the actual 510(k) submission or supporting clinical/performance study reports for the Randox Laboratories, Ltd. evidence® Amphetamine Assay.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).