FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
FDA 510(k) K240351 · Assure Tech., LLC
510(k) numberK240351
Submission
- Device name
- FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
- Applicant
- Assure Tech., LLC
Wilmington, DE, US - Received
- February 5, 2024
- Decision date
- March 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGL – Test, Opiates, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupNGL · Traditional | Anhui Deepblue Medical Technological Co., Ltd. | 04/15/2025SE |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProNGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/20/2025SE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…NGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/06/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | Healgen Scientific,, LLC | 12/17/2024SE |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…NGL · Traditional | Eterbio, Inc. | 11/20/2024SE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 11/08/2024SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 10/04/2024SE |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…NGL · Traditional | Qingdao Hightop Biotech Co., Ltd. | 08/14/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/16/2024SE |
More from Guangzhou Wondfo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional | 07/17/2026SE |
| 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 |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…NFT · Traditional | 02/07/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | 01/15/2025SE |
| 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 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) cleared by the FDA?
FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) (K240351) received a 510(k) decision of Substantially Equivalent on March 6, 2024, 30 days after the submission was received.
What is the product code of K240351?
The FDA product code is NGL – Test, Opiates, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3650.