FDA product code DJG: Enzyme Immunoassay, Opiates
DJG is the FDA product code for enzyme immunoassay, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. FDA has cleared 215 510(k) submissions under DJG, 23 in the last five years, from 86 different applicants. The average 510(k) review took 132 days (median 88); 131 days on average over the last three years. FDA has posted 13 recalls for DJG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Opiates |
| 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 DJG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 159 |
| 2018 | 5 | 164 |
| 2019 | 3 | 184 |
| 2020 | 5 | 49 |
| 2021 | 3 | 412 |
| 2022 | 2 | 432 |
| 2023 | 10 | 227 |
| 2024 | 5 | 161 |
| 2025 | 3 | 34 |
| 2026 | 3 | 197 |
Compare with all 510(k) review times · Search every DJG clearance
Top DJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lin-Zhi International, Inc. | 16 | 2026-01-16 |
| Immunalysis Corporation | 11 | 2025-09-11 |
| Guangzhou Wondfo Biotech Co., Ltd. | 8 | 2015-07-01 |
| Syva Co. | 8 | 1999-01-22 |
| Medtox Diagnostics, Inc. | 7 | 2026-01-29 |
81 more applicants have DJG clearances. See the full list in Caduvo.
Most recent DJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252684 | Medtox Diagnostics, Inc. | Labcorp Fentanyl Urine Visual Test | 2026-01-29 | 157 |
| K250741 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex | 2026-01-23 | 318 |
| K253082 | Lin-Zhi International, Inc. | LZI Buprenorphine II Enzyme Immunoassay | 2026-01-16 | 115 |
| K252520 | Immunalysis Corporation | SEFRIA Hydrocodone Oral Fluid | 2025-09-11 | 31 |
| K251972 | Healgen Scientific,, LLC | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | 2025-08-15 | 50 |
Recalls for DJG devices
13 product recalls in 10 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code DJG?
DJG is the FDA product code for enzyme immunoassay, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is DJG?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJG?
Across 215 cleared submissions the average was 132 days from receipt to decision (median 88).
Which companies have the most DJG clearances?
Lin-Zhi International, Inc. (16); Immunalysis Corporation (11); Guangzhou Wondfo Biotech Co., Ltd. (8); Syva Co. (8); Medtox Diagnostics, Inc. (7).
Have DJG devices been recalled?
Yes: 13 product recalls across 10 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code DJG
- Run a recall and safety report across every DJG manufacturer
- Watch product code DJG 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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