Cleared Traditional

K261984 - AssureTech Quick Cup Tests

Also marketed or referenced as:
AssureTech Multi-drug Urine Test Cup

K261984 is the FDA 510(k) clearance for AssureTech Quick Cup Tests by Assure Tech., LLC. It is a Class 2 Toxicology device (product code NFT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K261984 · Assure Tech., LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
35d
Days
Class 2
Risk

K261984 is an FDA 510(k) clearance for the AssureTech Quick Cup Tests. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on July 17, 2026 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Assure Tech., LLC devices

Submission Details

510(k) Number K261984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2026
Decision Date July 17, 2026
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - NFT Test, Amphetamine, Over The Counter

All 29
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K261984.
BioSieve Multi-Drug Urine Test Panel
K261280 · Vivachek Biotech (Hangzhou) Co., Ltd. · May 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2026
Webest Multi-Drug Urine Cup
K260355 · WEBEST Biotech,, LLC · Mar 2026
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2025
VINScreen Urine Drug Test Cup
K252867 · Advin Biotech, Inc. · Oct 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 2025