Submission Details
| 510(k) Number | K252259 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 21, 2025 |
| Decision Date | August 15, 2025 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
Aug 2025
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K252259 is an FDA 510(k) clearance for the AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on August 15, 2025, 25 days after receiving the submission on July 21, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | NFT — Test, Amphetamine, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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