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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 / May 2026 / K261280

510(k) cleared

BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel

Vivachek Biotech (Hangzhou) Co., Ltd. · May 22, 2026 · K261280

FDA cleared the BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel from Vivachek Biotech (Hangzhou) Co., Ltd. on May 22, 2026 under K261280, 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 Apr 17, 2026. The decision came 35 days later, inside the 90 FDA-day goal for a 510(k).

Vivachek Biotech (Hangzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K252554 (Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup).

Questions & Answers

What did FDA clear under K261280?

K261280 is the FDA 510(k) for BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel, submitted by Vivachek Biotech (Hangzhou) Co., Ltd.. FDA's decision date was May 22, 2026, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel?

Vivachek Biotech (Hangzhou) Co., Ltd., based in Hangzhou, is the applicant of record for K261280.

How long did the K261280 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on May 22, 2026, 35 days later.

← All decisions in May 2026

Sources