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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252684

510(k) cleared

Labcorp Fentanyl Urine Visual Test

Medtox Diagnostics, Inc. · Jan 29, 2026 · K252684

FDA cleared the Labcorp Fentanyl Urine Visual Test from Medtox Diagnostics, Inc. on Jan 29, 2026 under K252684, a traditional 510(k). The device falls under product code DJG, Enzyme Immunoassay, Opiates, regulated at 21 CFR 862.3650 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Aug 25, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medtox Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252684?

K252684 is the FDA 510(k) for Labcorp Fentanyl Urine Visual Test, submitted by Medtox Diagnostics, Inc.. FDA's decision date was Jan 29, 2026, under product code DJG (Enzyme Immunoassay, Opiates).

Who makes the Labcorp Fentanyl Urine Visual Test?

Medtox Diagnostics, Inc., based in Burlington, NC, is the applicant of record for K252684.

How long did the K252684 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Jan 29, 2026, 157 days later.

← All decisions in January 2026