Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay that qualitatively detects 17 drugs and metabolites (including amphetamine, cocaine, opiates, benzodiazepines, THC, and others) in human urine at specified cutoff concentrations. The Deepblue Home Multi-Drug Urine Test Cup is a similar rapid qualitative immunoassay for preliminary detection of drugs in urine. Both are available in single or multi-test cup configurations, optionally with on-board adulteration/specimen validity tests, and are intended for prescription use or over-the-counter use.

Both devices use competitive binding, lateral flow immunochromatographic assays based on antigen-antibody reactions and are qualitative tests using human urine specimens. The key difference from the predicate (Healgen Accurate Urine Drug Screen Dip Card, K240686) is physical form: the Deepblue devices are cup-format in ready-to-use sealed aluminum pouches, whereas the predicate is a dip card format. The Deepblue devices include Fentanyl detection (at 1 ng/mL cutoff), which the predicate does not.

Not stated in this summary.

Substantial equivalence is established through identical test methodology (competitive lateral flow immunochromatography), identical specimen type (human urine), identical qualitative purpose, and overlapping target drugs at equivalent cutoff concentrations (except fentanyl, which is a new analyte of concern). The submitter demonstrated equivalence through comprehensive analytical validation including precision testing across three lots and multiple concentrations, analytical specificity via cross-reactivity and interference studies, method comparison against LC-MS/MS on clinical samples, and lay-user studies showing >90% agreement at all concentration levels. The physical format change (cup versus dip card) does not alter the assay principle or performance; both are immunochromatographic lateral flow devices designed for the same preliminary drug-screening application.