Medtox Diagnostics, Inc. · Class II · Cleared Jan 29, 2026
| K-number | K252684 |
| Device name | Labcorp Fentanyl Urine Visual Test |
| Applicant | Medtox Diagnostics, Inc. |
| Product code | DJG |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay that detects norfentanyl (the primary fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is a single-use, in vitro diagnostic device in cassette format with a disposable dropper for sample transfer, intended for prescription use only. The test provides a preliminary qualitative result that must be confirmed by GC-MS, LC-MS/MS, or HPLC.
The subject device uses the same lateral flow competitive immunoassay technology as the predicate (colloidal gold-based), detects the same analyte (norfentanyl) at the same cutoff (5 ng/mL), and follows an identical test procedure. The key difference is the device format: the subject device is a cassette with a dropper, while the predicate (Chemtrue®) is a dip card or cup format. Both are single-use devices and qualitative only.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov