CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

The CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are lateral flow immunoassays designed to qualitatively detect 17 drugs and metabolites (including morphine, methamphetamine, cocaine, marijuana, fentanyl, and others) in human urine. The devices are cup-formatted, ready-to-use tests that provide preliminary screening results at specified cutoff concentrations, with results requiring confirmatory testing by GC/MS or LC/MS/MS.

Both devices employ competitive binding lateral flow immunochromatographic assay methodology based on antigen-antibody reactions. The devices are identical in format and test principle to the predicate (AllTest Multi-Drug Urine Test Cup K250727). Key differences are minor: the CLUNGENE devices offer flexible cutoff configurations for some analytes (e.g., morphine at 300 or 2000 ng/mL; methamphetamine at 500 or 1000 ng/mL) and support combination testing of 1-17 drugs in a single cup, whereas the predicate had fixed cutoff concentrations.

Not stated in this summary.

Substantial equivalence is established through comprehensive analytical performance matching: (1) identical test methodology (competitive binding lateral flow immunoassay); (2) identical specimen type (human urine) and intended use (qualitative drug screening, OTC); (3) identical device configuration (cup format, ready-to-use); (4) precision studies across three lots with 90-100% agreement at cutoff boundaries; (5) method comparison against LC-MS/MS on 80 clinical samples per drug showing excellent concordance; (6) lay-user study (280 participants) demonstrating 90-100% agreement at all concentration ranges; and (7) cross-reactivity and interference profiles comparable to predicate with no unexpected safety signals.