BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel— 510(k) K261280

Name: FDA 510(k) clearance K261280
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K261280 for BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel, Substantially Equivalent on 2026-05-22. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Summary

Vivachek Biotech (Hangzhou) filed two items, the BioSieve Multi-Drug Urine Test Panel and the BioSieve Multi-Drug Urine Home Test Panel, under NFT, over the counter amphetamine tests.

Class II, 21 CFR 862.3100. Clinical Toxicology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Vivachek filed from Hangzhou, China. The decision came 35 calendar days after receipt (April 17 to May 22, 2026).

Clearance details

Device name as filed: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Product code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2026-04-17
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel— 510(k) K261280

Summary

Clearance details

Recent devices under product code NFT

More clearances from Vivachek Biotech (Hangzhou) Co., Ltd.