FDA product code LDJ: Enzyme Immunoassay, Cannabinoids
LDJ is the FDA product code for enzyme immunoassay, cannabinoids. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel. FDA has cleared 150 510(k) submissions under LDJ, 3 in the last five years, from 75 different applicants. The average 510(k) review took 112 days (median 80); 134 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 15 recalls for LDJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Cannabinoids |
| Device class | Class II |
| Regulation | 21 CFR 862.3870 |
| 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 LDJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 28 |
| 2023 | 1 | 161 |
| 2024 | 2 | 134 |
Compare with all 510(k) review times · Search every LDJ clearance
Top LDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 17 | 2000-01-18 |
| Roche Diagnostic Systems, Inc. | 11 | 1998-12-11 |
| Abbott Laboratories | 8 | 2002-03-13 |
| Microgenics Corp. | 5 | 2011-04-08 |
| Amedica Biotech, Inc. | 4 | 2008-08-19 |
70 more applicants have LDJ clearances. See the full list in Caduvo.
Most recent LDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232732 | Co-Innovation Biotech Co., Ltd. | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | 2024-01-17 | 132 |
| K232604 | Hangzhou Laihe Biotech Co., Ltd. | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | 2024-01-10 | 135 |
| K223162 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | 2023-03-17 | 161 |
| K192515 | Shenzhen Bioeasy Biotechnology Co., Ltd. | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | 2019-10-11 | 28 |
| K153741 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | 2016-03-18 | 81 |
Recalls for LDJ devices
15 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2020 | 8 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code LDJ?
LDJ is the FDA product code for enzyme immunoassay, cannabinoids. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel.
What device class is LDJ?
Class II, regulation 21 CFR 862.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDJ?
Across 150 cleared submissions the average was 112 days from receipt to decision (median 80).
Which companies have the most LDJ clearances?
Syva Co. (17); Roche Diagnostic Systems, Inc. (11); Abbott Laboratories (8); Microgenics Corp. (5); Amedica Biotech, Inc. (4).
Have LDJ devices been recalled?
Yes: 15 product recalls across 7 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code LDJ
- Run a recall and safety report across every LDJ manufacturer
- Watch product code LDJ 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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