Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

The Webest Multi-Drug Urine Cup and Webest Home Multi-Drug Urine Cup are rapid lateral flow immunoassays for qualitative detection of multiple drugs of abuse in human urine. The devices can detect up to 19 different analytes including amphetamine, cocaine, opioids, benzodiazepines, cannabinoids, and other controlled substances at specified cutoff concentrations. Results are preliminary only and require confirmatory testing by GC-MS or LC-MS.

Both devices use competitive binding lateral flow immunochromatographic assay methodology with monoclonal antibodies. The devices are cup-format immunoassays in ready-to-use format sealed with desiccant sachets in aluminum pouches. They can be configured as single or multi-test cups with any combination of up to 19 analytes, with or without on-board adulteration/specimen validity tests.

Not stated in this summary.

The Webest devices are substantially equivalent to the AllTest Multi-Drug Rapid Test Cup (K244043) predicate because they use identical methodology (competitive binding lateral flow immunoassay), same specimen type (human urine), same intended use (qualitative detection for over-the-counter use), same test cup configuration, and nearly identical target drugs and cutoff values. Comprehensive performance data including precision, specificity, method comparison to LC-MS/MS, and lay-user studies demonstrate equivalent analytical performance to the predicate.