(136 days)
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.
For in vitro diagnostic use only.
As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method
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This looks like a 510(k) summary, but unfortunately, the provided document is a letter stating the FDA's decision regarding the device's substantial equivalence, along with the Indications for Use. It does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.
Therefore, I cannot extract the requested information. The document primarily focuses on the regulatory approval process and the intended use of the device, rather than the specific performance data and study design.
To provide the requested details, I would need access to the actual 510(k) submission or a performance study report for the "One Step DOA-2, DOA-4 Multi-Panel Test" and its single-analyte counterparts.
§ 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).