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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 / October 2025 / K252867

510(k) cleared

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Advin Biotech, Inc. · Oct 9, 2025 · K252867

FDA cleared the VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup from Advin Biotech, Inc. on Oct 9, 2025 under K252867, a traditional 510(k). The device falls under product code NFT, Test, Amphetamine, Over The Counter, regulated at 21 CFR 862.3100 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Sep 9, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252867?

K252867 is the FDA 510(k) for VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup, submitted by Advin Biotech, Inc.. FDA's decision date was Oct 9, 2025, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup?

Advin Biotech, Inc., based in San Diego, CA, is the applicant of record for K252867.

How long did the K252867 review take?

FDA received the submission on Sep 9, 2025 and issued its decision on Oct 9, 2025, 30 days later.

← All decisions in October 2025