Healgen Scientific,, LLC · Class II · Cleared Dec 23, 2025
| K-number | K253567 |
| Device name | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
| Applicant | Healgen Scientific,, LLC |
| Product code | NGL |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
The Healgen Accurate Urine Drug Screen Dip Card and Healgen Accurate Home Urine Drug Test Dip Card are rapid immunoassay lateral flow devices that qualitatively detect up to 18 different drugs and metabolites in human urine, including opiates, amphetamines, cocaine, benzodiazepines, and others at specified cut-off concentrations. These dip card devices are ready-to-use, require no assembly, and provide preliminary screening results that must be confirmed by alternative methods such as GC-MS or LC-MS.
Both devices use competitive immunoassay methodology with lateral flow chromatographic absorption technology employing mouse monoclonal antibody conjugates. The predicate device (K240686) uses the same methodology and specimen type; the new device adds two new analytes (Norfentanyl at 5 ng/mL and Tramadol at 100 ng/mL) not present in the predicate. The device format remains a dip card in an aluminum pouch with desiccant, requiring no assembly before use.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov