Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

The Dochek® Multi-Drug Urine Test Cup and Dochek® Multi-Drug Urine Test Cup Pro are immunoassay devices that qualitatively detect single or multiple drugs of abuse in human urine samples using a lateral flow format integrated into a plastic cup. The devices are intended for over-the-counter or professional use as preliminary screening tests, with results requiring confirmatory testing by GC/MS or LC/MS.

Both devices use competitive binding lateral flow immunochromatographic assay methodology based on antigen-antibody reactions. The key difference from the predicate is the addition of fentanyl detection at a 1 ng/mL cutoff, bringing the total detectable drugs from 16 to 17. The devices are ready-to-use cup format with integrated test strips sealed in aluminum foil pouches with desiccant, requiring no assembly before use.

Not stated in this summary.

The devices are substantially equivalent because they employ the identical competitive binding lateral flow immunochromatographic methodology as the predicate device (K232659), with the same specimen type (human urine), qualitative test approach, and 16 of 17 drug cutoff levels unchanged. The sole addition—fentanyl at 1 ng/mL—uses the same assay principle and was validated through comprehensive precision studies, cross-reactivity testing, and lay-user studies showing equivalent or superior performance. The method comparison and lay-user studies demonstrate the fentanyl assay performs consistently with the other drug tests in the panel.