FDA 510(k) clearance · back to tracker

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

Vivachek Biotech (Hangzhou) Co., Ltd. cleared K261280 on 2026-05-22, decision: substantially equivalent

K-number

K261280

Sponsor

Vivachek Biotech (Hangzhou) Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-22

Product code

NFT

Advisory committee

Clinical Toxicology

Medical specialty

Clinical Toxicology

Regulation number

862.3100

Official FDA record

Open K261280on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K261280 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.