AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

The AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup are lateral flow immunochromatographic assays that detect 19 drugs of abuse simultaneously in human urine specimens, including amphetamine, cocaine, marijuana, opioids, benzodiazepines, and others at specified cutoff concentrations. The devices are single-use, over-the-counter diagnostic kits providing preliminary qualitative results that require confirmatory testing by GC/MS or LC/MS.

Both the device and predicate use competitive binding, lateral flow immunochromatographic technology based on antigen-antibody reactions. The device adds detection capability for 6-Monoacetylmorphine, Tramadol, and alternate cutoff levels (AMP 300, MET 300, THC 20, MOR 2000) not present in the predicate K243996, but retains the same core immunoassay platform, specimen type (urine), qualitative result format, and over-the-counter configuration.

Not stated in this summary.

Substantial equivalence is established through identical test principle (lateral flow immunoassay), specimen type (human urine), intended use (over-the-counter drug screening), and test methodology. Performance data for new analytes (AMP300, MET300, TML100) demonstrate precision, stability, interference resistance, and specificity comparable to predicate data cited from prior 510(k) submissions. Method comparison and lay-user studies show clinical agreement with LC/MS reference results and high accuracy across multiple operators and concentrations, supporting the conclusion that expanded drug detection capability does not alter the fundamental safety and effectiveness profile.