AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup— 510(k) K261984
Substantially EquivalentAssure Tech., LLC
FDA 510(k) clearance K261984 for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup, Substantially Equivalent on 2026-07-17. Applicant: Assure Tech., LLC. Device class: 2.
Summary
Assure Tech's clearance covers AssureTech Quick Cup Tests and the AssureTech Multi-drug Urine Test Cup, filed under NFT, over-the-counter amphetamine tests. The record doesn't list the drugs the cups test for beyond that code name.
Class II, 21 CFR 862.3100. Clinical Toxicology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Assure Tech filed from Wilmington, Delaware. The decision came 35 calendar days after FDA received it (June 12 to July 17, 2026).
Clearance details
- Device name as filed
- AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
- Applicant
- Assure Tech., LLC
- Product code
- Product 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
- Wilmington, DE, US
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- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
More clearances from Assure Tech., LLC
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- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.