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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.

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