Healgen Scientific,, LLC · Class II · Cleared Mar 16, 2026
| K-number | K253705 |
| Device name | Healgen® Accurate Oral Fluid Drug Test |
| Applicant | Healgen Scientific,, LLC |
| Product code | DJC |
| Device class | Class II |
| Decision date | Mar 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.3610 |
The Healgen® Accurate Oral Fluid Drug Test is a lateral flow immunochromatographic assay that detects eight drugs (amphetamine, cocaine, marijuana, methadone, methamphetamine, opiates, oxycodone, and phencyclidine) in human oral fluid at specified cutoff concentrations. It provides preliminary qualitative results and is intended for prescription use, with confirmed results requiring LC-MS/MS analysis.
The device uses competitive binding lateral flow immunochromatographic methodology with the same calibrators, cutoff values, specimen type (human oral fluid), and test principle as the predicate. The only physical difference is device format: the Healgen uses a rectangular prism-shaped cup while the predicate uses a half cylinder-shaped cup.
Not stated in this summary.
Substantial equivalence is established because the Healgen device has identical indications for use, methodology, calibrators, cutoff values, and specimen type as the predicate device (Premier Biotech OralTox® K181305). Performance data from precision-reproducibility studies across three device lots, interference testing, specificity testing, and method comparison studies at six sites (1,430 samples) demonstrate equivalent analytical performance with overall accuracy ranging from 86-100% depending on drug concentration ranges.
View the full FDA submission: accessdata.fda.gov