Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

The Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit is a qualitative urine drug test designed to detect fentanyl at a cutoff of 1.0 ng/mL. It uses fluorescent microsphere-labeled antibodies in a competitive binding format and requires the Healgen Immunofluorescence Analyzer OG-H180 for result interpretation. The assay is intended for prescription use only and provides preliminary results that must be confirmed by GC-MS or LC-MS.

The device uses competitive immunofluorescence immunochromatography with fluorescent microsphere-labeled antibodies on a lateral-flow cassette format. The analyzer features a 2.8-inch LCD display (versus 1.54 inches on the predicate), slightly larger dimensions (13.52 × 8.38 × 4.3 cm), a rechargeable 3.7V 2200mAh lithium-ion battery, and LED light source. Both test kit and analyzer are functionally equivalent to the BioSieve predicate in methodology, specimen type, cutoff value, and intended use.

Not stated in this summary. The document references LC-MS/MS as the confirmatory method but does not cite specific consensus standards (ISO, IEC, ASTM, CLIA) for validation or performance.

Substantial equivalence is established through identical intended use (qualitative fentanyl detection in urine at 1.0 ng/mL), identical test methodology (competitive immunofluorescence on lateral-flow cassette), and identical specimen type and configuration. Comprehensive performance data—including precision across multiple concentration levels, broad interference testing with 100+ compounds, specificity studies against 40+ fentanyl analogs, and three-site clinical comparison studies showing 97.5% concordance with LC-MS/MS—demonstrate that the new device performs equivalently to the predicate. Minor instrumental differences (display size, weight, battery capacity) do not affect the analytical function or safety/effectiveness profile.