FDA product code NGL: Test, Opiates, Over The Counter
NGL is the FDA product code for test, opiates, over the counter. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. FDA has cleared 23 510(k) submissions under NGL, 18 in the last five years, from 16 different applicants. The average 510(k) review took 52 days (median 40); 60 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Opiates, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3650 |
| 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 NGL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 21 |
| 2019 | 1 | 28 |
| 2020 | 1 | 46 |
| 2023 | 1 | 16 |
| 2024 | 13 | 49 |
| 2025 | 4 | 70 |
Compare with all 510(k) review times · Search every NGL clearance
Top NGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Healgen Scientific,, LLC | 4 | 2025-12-23 |
| Hangzhou Clongene Biotech Co., Ltd. | 3 | 2024-11-08 |
| Guangzhou Decheng Biotechnology Co., Ltd. | 2 | 2025-02-20 |
| Amedica Biotech, Inc. | 2 | 2010-04-14 |
| Anhui Deepblue Medical Technological Co., Ltd. | 1 | 2025-04-15 |
11 more applicants have NGL clearances. See the full list in Caduvo.
Most recent NGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253567 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | 2025-12-23 | 36 |
| K250803 | Anhui Deepblue Medical Technological Co., Ltd. | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025-04-15 | 29 |
| K250067 | Guangzhou Decheng Biotechnology Co., Ltd. | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | 2025-02-20 | 41 |
| K242428 | Guangzhou Decheng Biotechnology Co., Ltd. | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | 2025-02-06 | 175 |
| K243365 | Healgen Scientific,, LLC | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | 2024-12-17 | 49 |
Recalls for NGL devices
openFDA lists no recalls for product code NGL.
Frequently asked questions
What is FDA product code NGL?
NGL is the FDA product code for test, opiates, over the counter. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is NGL?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGL?
Across 23 cleared submissions the average was 52 days from receipt to decision (median 40).
Which companies have the most NGL clearances?
Healgen Scientific,, LLC (4); Hangzhou Clongene Biotech Co., Ltd. (3); Guangzhou Decheng Biotechnology Co., Ltd. (2); Amedica Biotech, Inc. (2); Anhui Deepblue Medical Technological Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NGL
- Run a recall and safety report across every NGL manufacturer
- Watch product code NGL 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.
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