AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
FDA 510(k) K261984 · Assure Tech., LLC
510(k) numberK261984
Submission
- Device name
- AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
- Applicant
- Assure Tech., LLC
Wilmington, DE, US - Received
- June 12, 2026
- Decision date
- July 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFT – Test, Amphetamine, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261409 | BioTeke® Multi-Drug Urine Test CupNFT · Traditional | Bioteke Corporation (Wuxi) Co., Ltd. | 09/10/2026SE |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 05/22/2026SE |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/28/2026SE |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupNFT · Traditional | WEBEST Biotech,, LLC | 03/09/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/18/2025SE |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupNFT · Traditional | Advin Biotech, Inc. | 10/09/2025SE |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 09/12/2025SE |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 08/27/2025SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 08/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
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| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | 06/05/2026SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | 08/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | 02/13/2025SE |
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| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | 01/15/2025SE |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL · Traditional | 03/06/2024SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | 02/24/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | 10/05/2015SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | 06/04/2015SE |
Questions and answers
When was AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup cleared by the FDA?
AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984) received a 510(k) decision of Substantially Equivalent on July 17, 2026, 35 days after the submission was received.
What is the product code of K261984?
The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.