FDA product code NFT: Test, Amphetamine, Over The Counter
NFT is the FDA product code for test, amphetamine, over the counter. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 32 510(k) submissions under NFT, 21 in the last five years, from 15 different applicants. The average 510(k) review took 61 days (median 42); 49 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Amphetamine, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NFT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 117 |
| 2018 | 6 | 83 |
| 2019 | 1 | 29 |
| 2020 | 2 | 26 |
| 2021 | 1 | 209 |
| 2022 | 3 | 62 |
| 2023 | 1 | 37 |
| 2024 | 4 | 32 |
| 2025 | 8 | 45 |
| 2026 | 5 | 69 |
Compare with all 510(k) review times · Search every NFT clearance
Top NFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vivachek Biotech (Hangzhou) Co., Ltd. | 4 | 2026-05-22 |
| Guangzhou Wondfo Biotech Co., Ltd. | 4 | 2026-04-28 |
| Hangzhou AllTest Biotech Co., Ltd. | 4 | 2025-04-04 |
| Assure Tech., LLC | 3 | 2026-07-17 |
| Safecare Biotech (Hangzhou) Co., Ltd. | 3 | 2021-03-24 |
10 more applicants have NFT clearances. See the full list in Caduvo.
Most recent NFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261409 | Bioteke Corporation (Wuxi) Co., Ltd. | BioTeke® Multi-Drug Urine Test Cup | 2026-09-10 | 133 |
| K261984 | Assure Tech., LLC | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | 2026-07-17 | 35 |
| K261280 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | 2026-05-22 | 35 |
| K260065 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | 2026-04-28 | 109 |
| K260355 | WEBEST Biotech,, LLC | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | 2026-03-09 | 34 |
Recalls for NFT devices
openFDA lists no recalls for product code NFT.
Frequently asked questions
What is FDA product code NFT?
NFT is the FDA product code for test, amphetamine, over the counter. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is NFT?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFT?
Across 32 cleared submissions the average was 61 days from receipt to decision (median 42).
Which companies have the most NFT clearances?
Vivachek Biotech (Hangzhou) Co., Ltd. (4); Guangzhou Wondfo Biotech Co., Ltd. (4); Hangzhou AllTest Biotech Co., Ltd. (4); Assure Tech., LLC (3); Safecare Biotech (Hangzhou) Co., Ltd. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code NFT
- Run a recall and safety report across every NFT manufacturer
- Watch product code NFT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times