# K252684: Labcorp Fentanyl Urine Visual Test

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jan 29, 2026 after 157 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K964355 (1996). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232736: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test, Chemtron Biotech, Inc. (2023) Summary page 5.

## Indications for use
The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay for the rapid qualitative detection of norfentanyl (fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is intended for prescription use. For in vitro diagnostic use only. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. To confirm preliminary positive results, a more specific analytical method must be used. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods.

Source page: https://510kreport.com/device/K252684
Methodology: https://510kreport.com/methodology