AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

The AllTest Multi-Drug Urine Test Cup is an immunochromatographic lateral flow assay for qualitative detection of up to 18 different drugs and metabolites in human urine, including amphetamines, opioids, benzodiazepines, cocaine, and others at specified cutoff concentrations. It is intended for over-the-counter use as a preliminary screening test, with results requiring confirmation by GC/MS or LC/MS.

The device uses competitive binding, lateral flow immunochromatographic assays with drug monoclonal antibody conjugates. It is formatted as a cup with multiple test strips, each sealed with desiccants in aluminum pouches. The device is ready-to-use and provides results through colored test lines at control and test regions, with the same test principle, specimen type (human urine), qualitative methodology, and target drugs at identical cutoff values as the predicate device K244043.

Not stated in this summary.

Substantial equivalence is supported by: (1) identical intended use—qualitative detection of drugs of abuse in urine for OTC or prescription use; (2) same test methodology—competitive binding lateral flow immunochromatographic assays; (3) identical target drugs and cutoff concentrations across 18 analytes; (4) comprehensive performance data showing precision across three lots with results at ±100% cutoff levels, analytical specificity with documented cross-reactivity percentages, stability at 2–30°C for 24 months, and method comparison concordance >95% with LC-MS/MS; and (5) lay-user study demonstrating 90–100% agreement with reference testing at cutoff and surrounding concentrations.