SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx

SAFElife™ T-Dip Multi-Drug Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of up to 15 drugs of abuse in human urine, including amphetamines, opioids, cocaine, cannabinoids, and others at specified cutoff concentrations. The device provides preliminary screening results only; GC/MS or LC/MS confirmation is required for definitive analysis.

The candidate device uses the same competitive binding, lateral flow immunochromatographic methodology as the predicate (K202567). Key differences include addition of four new analytes (6-MAM10, FTY1, NFTY5, TRA100) and two new THC cutoff options (THC20 and THC50). The physical design—test panel sealed with desiccant in aluminum pouch with package insert—remains identical to the predicate.

Not stated in this summary. The document references GC/MS and LC/MS as confirmatory methods but does not cite specific consensus standards (ISO, IEC, ASTM, etc.).

Substantial equivalence is based on identical test principle, specimen type, and qualitative methodology compared to the predicate. New analytes and cutoff concentrations were supported by acceptable precision/reproducibility data, analytical specificity studies, interference testing, method comparison studies versus LC/MS/GC/MS, and lay-user studies demonstrating performance consistency across multiple lots and operators.