FDA product code DLJ: Calibrators, Drug Specific
DLJ is the FDA product code for calibrators, drug specific. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel. FDA has cleared 123 510(k) submissions under DLJ, from 30 different applicants. The average 510(k) review took 59 days (median 43). FDA has posted 5 recalls for DLJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrators, Drug Specific |
| Device class | Class II |
| Regulation | 21 CFR 862.3200 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DLJ clearance
Top DLJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 21 | 1993-11-09 |
| Syva Co. | 18 | 1990-12-26 |
| Innotron of Oregon, Inc. | 10 | 1990-08-22 |
| Dade Behring, Inc. | 8 | 2006-09-14 |
| Roche Diagnostic Systems, Inc. | 8 | 1998-12-15 |
25 more applicants have DLJ clearances. See the full list in Caduvo.
Most recent DLJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132090 | Randox Laboratories, Ltd. | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | 2013-08-08 | 27 |
| K091617 | Thermo Fisher Scientific | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | 2009-07-17 | 44 |
| K082030 | Siemens Healthcare Diagnostics, Inc. | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | 2008-08-22 | 36 |
| K062182 | Dade Behring, Inc. | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | 2006-09-14 | 45 |
| K062199 | Dade Behring, Inc. | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | 2006-09-06 | 36 |
Recalls for DLJ devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-04-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code DLJ?
DLJ is the FDA product code for calibrators, drug specific. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel.
What device class is DLJ?
Class II, regulation 21 CFR 862.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DLJ?
Across 123 cleared submissions the average was 59 days from receipt to decision (median 43).
Which companies have the most DLJ clearances?
E.I. Dupont DE Nemours & Co., Inc. (21); Syva Co. (18); Innotron of Oregon, Inc. (10); Dade Behring, Inc. (8); Roche Diagnostic Systems, Inc. (8).
Have DLJ devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2023-04-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DLJ
- Run a recall and safety report across every DLJ manufacturer
- Watch product code DLJ 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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