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

The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic lateral flow assays for qualitative detection of 18 drugs and metabolites in human urine, including amphetamines, opioids, benzodiazepines, cocaine, and others at specified cutoff concentrations. The devices are cup-format, ready-to-use, intended for over-the-counter screening only, and provide preliminary results requiring confirmatory testing by GC/MS or LC/MS.

Both devices use competitive binding, lateral flow immunochromatographic assays based on antigen-antibody reactions. The key difference from the predicate (K233019) is the addition of four new analytes: Fentanyl (1 ng/mL cutoff), Tramadol (100 ng/mL), Propoxyphene (300 ng/mL), and 6-monoacetylmorphine (10 ng/mL). The predicate included a dip card configuration; this submission is cup-format only.

Not stated in this summary.

Substantial equivalence is based on identical test principle (competitive binding lateral flow immunoassay), specimen type (human urine), and test characteristics (qualitative, same intended use for OTC drug screening) as the predicate. Performance data for the four new analytes—precision across cutoff concentrations, analytical specificity, method comparison to LC-MS/MS, and lay-user studies—all demonstrate equivalent or superior performance boundaries and accuracy. Interference testing and pH/specific gravity robustness match predicate standards. The addition of analytes does not change the fundamental mechanism or safety profile, only expands detection capability.