BioTeke® Multi-Drug Urine Test Cup— 510(k) K261409
Substantially EquivalentBioteke Corporation (Wuxi) Co., Ltd.
FDA 510(k) clearance K261409 for BioTeke® Multi-Drug Urine Test Cup, Substantially Equivalent on 2026-09-10. Applicant: Bioteke Corporation (Wuxi) Co., Ltd.. Device class: 2.
Summary
The BioTeke Multi-Drug Urine Test Cup is a drugs-of-abuse screening cup, the kind that tests one urine sample for several drug classes at once. The record lists product code NFT, over-the-counter amphetamine tests. Multi-drug cups carry a separate code for each drug, and the record only shows the primary one.
Class II, 21 CFR 862.3100. The Clinical Toxicology panel reviewed it as a Traditional 510(k). Because it's an OTC product, the submission needed lay-user studies on top of the analytical testing.
Bioteke Corporation filed from Wuxi, China. Review took 133 days (April 30 to September 10, 2026).
Clearance details
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
- Product code
- Code NFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
Recent devices under product code NFT
view all- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
More clearances from Bioteke Corporation (Wuxi) Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.