FDA product code DJR: Enzyme Immunoassay, Methadone
DJR is the FDA product code for enzyme immunoassay, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. FDA has cleared 63 510(k) submissions under DJR, from 36 different applicants. The average 510(k) review took 114 days (median 76). FDA has posted 7 recalls for DJR devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Methadone |
| Device class | Class II |
| Regulation | 21 CFR 862.3620 |
| 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 DJR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 136 |
| 2018 | 1 | 51 |
| 2019 | 1 | 29 |
Compare with all 510(k) review times · Search every DJR clearance
Top DJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 6 | 2000-01-20 |
| Lin-Zhi International, Inc. | 5 | 2019-10-04 |
| W.H.P.M., Inc. | 3 | 2016-08-17 |
| Randox Laboratories, Ltd. | 3 | 2010-11-18 |
| Abbott Laboratories | 3 | 2002-03-20 |
31 more applicants have DJR clearances. See the full list in Caduvo.
Most recent DJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192433 | Lin-Zhi International, Inc. | LZI Methadone II Enzyme Immunoassay | 2019-10-04 | 29 |
| K182779 | Ark Diagnostics, Inc. | ARK EDDP Assay | 2018-11-21 | 51 |
| K170416 | Lin-Zhi International, Inc. | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | 2017-06-26 | 136 |
| K160793 | W.H.P.M., Inc. | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | 2016-08-17 | 147 |
| K152025 | Assure Tech. Co., Ltd. | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | 2015-10-05 | 75 |
Recalls for DJR devices
7 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code DJR?
DJR is the FDA product code for enzyme immunoassay, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel.
What device class is DJR?
Class II, regulation 21 CFR 862.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJR?
Across 63 cleared submissions the average was 114 days from receipt to decision (median 76).
Which companies have the most DJR clearances?
Syva Co. (6); Lin-Zhi International, Inc. (5); W.H.P.M., Inc. (3); Randox Laboratories, Ltd. (3); Abbott Laboratories (3).
Have DJR devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2017-11-28.
Next steps
- Run an FDA pathway report with predicate devices for product code DJR
- Run a recall and safety report across every DJR manufacturer
- Watch product code DJR 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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