FDA product code DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
DIC is the FDA product code for alcohol dehydrogenase, specific reagent for ethanol enzyme method. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. FDA has cleared 33 510(k) submissions under DIC, 1 in the last five years, from 23 different applicants. The average 510(k) review took 126 days (median 77); 199 days on average over the last three years. FDA has posted 6 recalls for DIC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| 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 DIC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 140 |
| 2025 | 1 | 199 |
Compare with all 510(k) review times · Search every DIC clearance
Top DIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Chemicals , Ltd. | 4 | 2000-06-20 |
| Dade Behring, Inc. | 3 | 2007-08-24 |
| Abbott Laboratories | 3 | 1989-08-25 |
| Chematics, Inc. | 2 | 2013-03-22 |
| Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 2 | 1990-10-12 |
18 more applicants have DIC clearances. See the full list in Caduvo.
Most recent DIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250609 | Sober Ip, LLC | Sober Self-Test | 2025-09-15 | 199 |
| K181553 | Immunalysis Corporation | Immunalysis Ethyl Alcohol Enzyme Assay | 2018-10-31 | 140 |
| K121247 | Chematics, Inc. | ALCO-SCREEN | 2013-03-22 | 331 |
| K121256 | Chematics, Inc. | ALCO-SCREEN 02 | 2012-09-12 | 140 |
| K111005 | Medica Corp. | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | 2011-11-15 | 218 |
Recalls for DIC devices
6 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DIC?
DIC is the FDA product code for alcohol dehydrogenase, specific reagent for ethanol enzyme method. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DIC?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIC?
Across 33 cleared submissions the average was 126 days from receipt to decision (median 77).
Which companies have the most DIC clearances?
Diagnostic Chemicals , Ltd. (4); Dade Behring, Inc. (3); Abbott Laboratories (3); Chematics, Inc. (2); Enzymatics C/O Burditt,Bowles,Radzius & Ruberry (2).
Have DIC devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code DIC
- Run a recall and safety report across every DIC manufacturer
- Watch product code DIC 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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