SEFRIA™ Hydrocodone Oral Fluid

The SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay designed for qualitative and semi-quantitative detection of hydrocodone in human oral fluid samples collected using Quantisal™ or Quantisal™ II devices. It operates with a 30 ng/mL cutoff and is intended for use with automated clinical chemistry analyzers. Results are preliminary and require confirmation by mass spectrometry methods such as GC-MS or LC-MS/MS.

The subject device uses the same assay materials (ready-to-use antibody and drug conjugate reagents), test principle (homogenous competitive), measurement modes (qualitative and semi-quantitative), cutoff level (30 ng/mL in neat oral fluid), sample matrix (oral fluid), reagent storage conditions (2–8°C), and instrumentation (automated clinical chemistry analyzer) as the predicate device. The only substantive difference is the target analyte: hydrocodone instead of oxycodone.

Not stated in this summary.

The device demonstrates substantial equivalence through identical design and functionality to the predicate SEFRIA™ Oxycodone device, with comprehensive performance validation showing acceptable precision (100% accuracy at cutoff and above in qualitative mode), minimal cross-reactivity with structurally-related opioids, no interference from endogenous or exogenous compounds across tested concentrations, acceptable linearity and recovery (10–100 ng/mL range with ±15% recovery), stable calibration for 14 days, and 100% qualitative concordance with LC-MS/MS reference method for positive samples (92.5% for negatives). The change from oxycodone to hydrocodone as the target analyte does not alter the fundamental technology, methodology, or clinical application—both are preliminary screening assays requiring confirmatory testing.