Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

The Wisdiag Multi-Drug Urine Test Cup is a rapid, single-use immunochromatographic assay device that qualitatively detects up to 19 drugs of abuse simultaneously in human urine, including amphetamines, opioids, cocaine, benzodiazepines, cannabinoids, and others at specified cutoff concentrations. The Wisdiag Multi-Drug Urine Home Test Cup is the same technology marketed for over-the-counter home use. Both devices provide preliminary results requiring confirmatory testing by GC/MS or LC/MS.

The proposed device uses competitive binding, lateral flow immunochromatographic assay methodology identical to the predicate. It maintains the same qualitative test format, human urine specimen type, and cup configuration. The key difference is the addition of four new analytes—Tramadol (100 ng/mL), Fentanyl (1 ng/mL), 6-Monoacetylmorphine (10 ng/mL), and Norfentanyl (5 ng/mL)—which were not included in the predicate device K222667.

Not stated in this summary. The document references LC/MS and GC/MS as confirmatory methods but does not cite specific ISO, IEC, or ASTM consensus standards for the device validation.

Substantial equivalence is established through identical test principle, methodology, specimen type, and device configuration to the predicate. Comprehensive analytical performance data for the four new analytes (precision across nine concentration levels, specificity against 100+ potential cross-reactants, stability, and interference testing) demonstrate performance equivalent to the predicate's established analytes. Method comparison studies and lay-user studies with 280 participants achieved agreement rates of 90–100% across concentration ranges, confirming the new analytes perform reliably with the same immunoassay platform. The device maintains the same intended use and clinical context as the predicate.