Healgen Scientific,, LLC · Class II · Cleared Feb 12, 2026
| K-number | K252523 |
| Device name | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test |
| Applicant | Healgen Scientific,, LLC |
| Product code | NFW |
| Device class | Class II |
| Decision date | Feb 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.3870 |
The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow immunoassay that detects cotinine and marijuana (THC) in oral fluid samples at cutoff concentrations of 30 ng/mL and 40 ng/mL respectively. It provides preliminary qualitative results; confirmatory testing by LC/MS or GC/MS is required for positive findings. The device is intended for over-the-counter use.
The device uses competitive binding lateral flow immunochromatographic assay methodology, identical to the predicate. It detects the same analytes (cotinine and THC) at the same cutoff concentrations (30 ng/mL and 40 ng/mL) in human oral fluid specimens with the same qualitative test format.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov