Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

The Healgen® Accurate Multi-Drug Urine Drug Screen Cup is a rapid lateral flow immunoassay that qualitatively detects 17 drugs and drug metabolites in human urine, including opiates, amphetamines, cocaine, benzodiazepines, cannabis, and others. It is available in two formats: a clinical screening cup and an over-the-counter home test cup. Both provide preliminary results only; positive results require confirmatory testing by GC-MS or LC-MS/MS.

The device uses competitive binding lateral flow immunochromatographic assay technology identical to the predicate. The main difference is the form factor: the device is a cup format (versus a dip card predicate), eliminating the need for assembly before use. Both employ the same test principle with drug monoclonal antibody conjugates and pre-coated membranes with identical test regions and cutoff concentrations.

Not stated in this summary. The document references LC-MS/MS and GC-MS as confirmatory methods but does not cite specific consensus standards (ISO, IEC, ASTM, or CLIA) governing the device's analytical validation or performance requirements.

Substantial equivalence rests on identical intended use (qualitative detection of drugs in urine for screening), identical methodology (competitive immunochromatographic assay with monoclonal antibodies), identical specimen type (human urine), and equivalent target drugs and cutoff values compared to predicate K240686. Performance data—including precision across multiple lots and operators, specificity/cross-reactivity studies, method comparison to LC-MS/MS on clinical samples (showing good concordance), and lay-user studies demonstrating 90–100% agreement at cutoff ±25%—all support equivalent analytical performance. The only material difference—cup versus dip card format—does not affect the test principle, performance, or safety profile; rather, it improves usability by eliminating assembly steps.