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

The AssureTech Panel Dip Tests, Quick Cup Tests, Multi-drug Urine Test Panel, and Multi-drug Urine Test Cup are immunochromatographic assays for qualitative, preliminary detection of up to 17 drugs of abuse in human urine, including amphetamine, cocaine, marijuana, opioids (morphine, fentanyl, norfentanyl, oxycodone, buprenorphine), benzodiazepines, barbiturates, methadone, phencyclidine, and tricyclic antidepressants. The tests are for over-the-counter in vitro diagnostic use and require confirmatory testing by GC/MS or LC/MS.

The devices employ competitive binding, lateral flow immunochromatographic assays using monoclonal antibody-coated particles and immobilized drug conjugates. They detect analytes at established cutoff concentrations (ranging from 1 ng/mL for fentanyl to 1000 ng/mL for nortriptyline). Key difference from predicate K181768: addition of fentanyl and norfentanyl detection; predicate detected 15 analytes, these detect up to 17.

Not stated in this summary.

The devices employ identical test methodology (competitive binding lateral flow immunoassay) and specimen type (human urine) as predicate K181768, with the same intended use (qualitative preliminary drug screening). Precision studies at multiple cutoff concentrations (-100% to +100%) across three lots demonstrate consistent performance. Extensive interference testing of 150+ physiological and pathological urine compounds at clinically relevant concentrations shows no cross-reactivity. Specificity testing confirms detection of target analytes with minimal cross-reactivity to related compounds. Method comparison against LC/MS on 80 clinical samples per operator per analyte shows concordance. Lay-user studies with 280 untrained participants achieved ≥90% correct results across cutoff ranges. The addition of fentanyl and norfentanyl detection does not alter the fundamental assay principle or performance profile relative to the predicate.