Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
FDA product code DIC · Class II (moderate risk) · 21 CFR 862.3040 · Clinical Toxicology
33510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Diagnostic Chemicals , Ltd. 4
- Abbott Laboratories 3
- Dade Behring, Inc. 3
- Chematics, Inc. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- Enzymatics C/O Burditt,Bowles,Radzius & Ruberry 2
- Syva Co., Dade Behring, Inc. 1
- Lederle Laboratories 1
- Sober Ip, LLC 1
- Teco Diagnostics 1
- Randox Laboratories, Ltd. 1
- ACON Laboratories, Inc. 1
- Cooper Biomedical, Inc. 1
- Lin-Zhi International, Inc. 1
- Bayer Diagnostics Corp. 1
- Pointe Scientific, Inc., 1
- Behring Diagnostics, Inc. 1
- Baxter Diagnostics, Inc. 1
- Solarcare Technologies Corp,Inc. 1
- Roche Diagnostic Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250609 | Sober Self-TestDIC · Traditional | Sober Ip, LLC | 09/15/2025SE |
| K181553 | Immunalysis Ethyl Alcohol Enzyme AssayDIC · Traditional | Immunalysis Corporation | 10/31/2018SE |
| K121247 | Alco-ScreenDIC · Traditional | Chematics, Inc. | 03/22/2013SE |
| K121256 | Alco-Screen 02DIC · Traditional | Chematics, Inc. | 09/12/2012SE |
| K111005 | Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional | Medica Corp. | 11/15/2011SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | Teco Diagnostics | 10/04/2011SE |
| K092273 | Randox Ethanol AssayDIC · Traditional | Randox Laboratories, Ltd. | 11/01/2010SE |
| K093879 | Mission Saliva Alcohol Test StripDIC · Traditional | ACON Laboratories, Inc. | 08/06/2010SE |
| K071811 | Etoh Flex Reagent Cartridge (DF22)DIC · Traditional | Dade Behring, Inc. | 08/24/2007SE |
| K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022DIC · Traditional | Dade Behring, Inc. | 06/13/2007SE |
| K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…DIC · Special | Dade Behring, Inc. | 07/18/2006SE |
| K032461 | Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221DIC · Traditional | Lin-Zhi International, Inc. | 10/03/2003SE |
| K023184 | Ethanol Assay for the Bayer Advia Integrated Module SystemDIC · Traditional | Bayer Diagnostics Corp. | 11/18/2002SE |
| K010960 | Emit II Plus Ethyl Alcohol Assay, Model OSR9K229DIC · Special | Syva Co., Dade Behring, Inc. | 04/26/2001SE |
| K001286 | ETHANOL-L3K Assay, Models 273-30, 273-17, 273-10DIC · Traditional | Diagnostic Chemicals , Ltd. | 06/20/2000SE |
| K993920 | ETHANOL-L3K Assay, Catalogue Number 273-30, 273-17DIC · Traditional | Diagnostic Chemicals , Ltd. | 01/18/2000SE |
| K974002 | Ethanol-Sl Assay, Catalogue Number 240-12DIC · Traditional | Diagnostic Chemicals , Ltd. | 04/01/1998SE |
| K972725 | Alcohol Reagent SetDIC · Traditional | Pointe Scientific, Inc., | 09/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | Behring Diagnostics, Inc. | 07/22/1997SE |
| K955633 | Enthanol (Rate) Assay, Catalogue No. 219-03DIC · Traditional | Diagnostic Chemicals , Ltd. | 05/24/1996SE |
| K934275 | Paramax Alcohol ReagentDIC · Traditional | Baxter Diagnostics, Inc. | 04/26/1994SE |
| K931516 | STC Diagnostics Auto-Lyte(Tm) Ethyl Alcohol AssayDIC · Traditional | Solarcare Technologies Corp,Inc. | 07/19/1993SE |
| K913125 | Roche Reagent for EthanolDIC · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1991SE |
| K904302 | Dupont Dimension(R) Ethyl Alcohol(Alc) MethodDIC · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/12/1990SE |
| K903235 | Statlab A-350 Saliva Alcohol TestDIC · Traditional | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 10/12/1990SE |
| K903153 | Emit Ethyl Alcohol AssayDIC · Traditional | Syva Co. | 08/09/1990SE |
| K894001 | Saliva Alcohol TestDIC · Traditional | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 04/05/1990SE |
| K890743 | Ad X(Tm) EthanolDIC · Traditional | Abbott Laboratories | 08/25/1989SE |
| K881344 | Aca Ethyl Alcohol (Alc) Analytical Test PacksDIC · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/24/1989SE |
| K871645 | TDXR Rea(Tm) EthanolDIC · Traditional | Abbott Laboratories | 06/11/1987SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | Cooper Biomedical, Inc. | 11/05/1985SE |
| K840826 | TDX EthanolDIC · Traditional | Abbott Laboratories | 04/13/1984SE |
| K770975 | Anti-Convulsant Drug ControlDIC · Traditional | Lederle Laboratories | 06/08/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0727-2026 Class II | Alcohol (ALC) Test SalivaDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1599-2020 Class II | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI…The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. | Siemens Healthcare Diagnostics, Inc. | 02/14/2020Terminated |
| Z-1253-2019 Class III | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality… | Carolina Liquid Chemistries | 01/16/2019Terminated |
| Z-1252-2019 Class III | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | Carolina Liquid Chemistries | 01/16/2019Terminated |
| Z-1256-2019 Class III | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test…Shelf life of the product may be reduced due to degradation of the assay. | Lin-Zhi International Inc | 01/11/2019Terminated |
| Z-3104-2011 | Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue…Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the… | Express Diagnostics Int'l., Inc. | 11/01/2010Terminated |