Cleared Traditional

Labcorp Fentanyl Urine Visual Test

K252684 · Medtox Diagnostics, Inc. · Toxicology
Jan 2026
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K252684 is an FDA 510(k) clearance for the Labcorp Fentanyl Urine Visual Test, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on January 29, 2026, 157 days after receiving the submission on August 25, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K252684 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2025
Decision Date January 29, 2026
Days to Decision 157 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

Similar Devices — DJG Enzyme Immunoassay, Opiates

All 214
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · Randox Laboratories Limited · Jan 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · Lin-Zhi International, Inc. · Jan 2026
SEFRIA? Hydrocodone Oral Fluid
K252520 · Immunalysis Corporation · Sep 2025
Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180)
K251972 · Healgen Scientific, LLC · Aug 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · Lin-Zhi International, Inc. · Jun 2025
BioSieve? Fentanyl FIA Test Kit; BioSieve? ToxiSmart FIA Reader
K240124 · Vivachek Biotech (Hangzhou) Co., Ltd. · Jun 2024