LYHER® Oral fluid Multi-Drug Test Kit (Cube)

The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for qualitative detection of six drugs of abuse (amphetamine, methamphetamine, cocaine, opiates, PCP, and marijuana) in human oral fluid. It provides preliminary screening results; confirmatory testing by GC/MS or LC/MS is required for definitive diagnosis. The device consists of a cube-shaped test cartridge, an oral fluid collection swab, and package insert instructions.

The device uses lateral flow immunochromatographic technology with competitive binding principle, identical to the predicate OralTox™ device. The primary difference is physical form: the proposed device employs a cube configuration whereas the predicate uses cup-shaped devices. Both share identical cut-off concentrations, specimen type (oral fluid), qualitative methodology, and intended prescription-use indication.

Not stated in this summary.

Substantial equivalence is established through matching test principle (competitive binding lateral flow immunoassay), identical cut-off values for all six analytes, same specimen type and intended use, and comprehensive analytical performance data demonstrating acceptable precision (>80% positive agreement at cutoff across three operators and lots), minimal cross-reactivity with potential interfering substances at clinically relevant concentrations, and >95% agreement with LC/MS reference method across 1,900 clinical samples at three independent testing sites.