Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3040](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3040) → DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method # DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method _Clinical Toxicology · 21 CFR 862.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC ## Overview - **Product Code:** DIC - **Device Name:** Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method - **Regulation:** [21 CFR 862.3040](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3040) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) - **3rd-party reviewable:** yes ## Identification An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 33) Showing 20 most recent of 33 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250609](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K250609.md) | Sober Self-Test | Sober Ip, LLC | Sep 15, 2025 | SESE | | [K181553](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K181553.md) | Immunalysis Ethyl Alcohol Enzyme Assay | Immunalysis Corporation | Oct 31, 2018 | SESE | | [K121247](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K121247.md) | ALCO-SCREEN | Chematics, Inc. | Mar 22, 2013 | SESE | | [K121256](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K121256.md) | ALCO-SCREEN 02 | Chematics, Inc. | Sep 12, 2012 | SESE | | [K111005](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K111005.md) | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | Medica Corp. | Nov 15, 2011 | SESE | | [K111206](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K111206.md) | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Teco Diagnostics | Oct 4, 2011 | SESE | | [K092273](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K092273.md) | RANDOX ETHANOL ASSAY | Randox Laboratories, Ltd. | Nov 1, 2010 | SESE | | [K093879](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K093879.md) | MISSION SALIVA ALCOHOL TEST STRIP | ACON Laboratories, Inc. | Aug 6, 2010 | SESE | | [K071811](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K071811.md) | ETOH FLEX REAGENT CARTRIDGE (DF22) | Dade Behring, Inc. | Aug 24, 2007 | SESE | | [K070853](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K070853.md) | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | Dade Behring, Inc. | Jun 13, 2007 | SESE | | [K061792](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K061792.md) | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI | Dade Behring, Inc. | Jul 18, 2006 | SESE | | [K032461](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K032461.md) | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | Lin-Zhi International, Inc. | Oct 3, 2003 | SESE | | [K023184](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K023184.md) | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | Nov 18, 2002 | SESE | | [K010960](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K010960.md) | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | Syva Co., Dade Behring, Inc. | Apr 26, 2001 | SESE | | [K001286](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K001286.md) | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | Diagnostic Chemicals , Ltd. | Jun 20, 2000 | SESE | | [K993920](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K993920.md) | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | Diagnostic Chemicals , Ltd. | Jan 18, 2000 | SESE | | [K974002](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K974002.md) | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | Diagnostic Chemicals , Ltd. | Apr 1, 1998 | SESE | | [K972725](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K972725.md) | ALCOHOL REAGENT SET | Pointe Scientific, Inc., | Sep 25, 1997 | SESE | | [K972011](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K972011.md) | OPUS ETHANOL | Behring Diagnostics, Inc. | Jul 22, 1997 | SESE | | [K955633](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K955633.md) | ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 | Diagnostic Chemicals , Ltd. | May 24, 1996 | SESE | ## Top Applicants - Diagnostic Chemicals , Ltd. — 4 clearances - Abbott Laboratories — 3 clearances - Dade Behring, Inc. — 3 clearances - Chematics, Inc. — 2 clearances - E.I. Dupont DE Nemours & Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com