Alco-Screen
Alco-Screen is an over-the-counter saliva screening test that estimates blood-alcohol concentration. It is a semiquantitative in vitro diagnostic test, providing concentration categories…
Alco-Screen is an over-the-counter saliva screening test that estimates blood-alcohol concentration. It is a semiquantitative in vitro diagnostic test, providing concentration categories rather than a continuous numerical measurement. Results are used in assessing alcohol use or intoxication.
Alcohol oxidase drives a colour-forming reaction on the test strip. The user reads the result visually by comparing the colour change with a reference chart. The chart represents estimated blood-alcohol levels of 0.00%, 0.02%, 0.04%, 0.08% and 0.3%.
Listed Item
ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use. 510K Cleared – CliaWaived
Test Strip Supply
The product contains 24 individually packaged strips with instructions for use. Each strip is disposable and intended for a single test using human saliva.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
Record
| Listed by | Chematics, Inc., United States |
|---|---|
| FDA product code | DIC |
| Device type | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3040 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K121247 |
| Record published | 2016-09-29 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 50 to 80 °F |
| Packaging | Box of 24, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immunalysis | Immunalysis Corporation | 4 |
| Wondfo | Wondfo USA Co., Ltd. | 4 |
| Ethanol Gen.2 | Roche Diagnostics Gmbh | 2 |
| Ethyl Alcohol Enzymatic Assay | LIN-ZHI International, Inc. | 2 |
| Wondfo Saliva Alcohol Test | Wondfo USA Co., Ltd. | 2 |
| Pointe Ethyl Alcohol Reagent Set | Horiba Instruments Incorporated | 2 |
| Pointe Scientific Alcohol | Horiba Instruments Incorporated | 2 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Ethanol Gen2 | Roche Diagnostics Gmbh | 1 |
| Teco Diagnostics | Teco Diagnostics | 1 |
| Atellica CH Ethanol (EtohC) | Siemens Healthcare Diagnostics Inc | 1 |
| MP Saliva Alcohol Test Strip | Rapid Diagnostics, Inc. | 1 |
Showing 12 of 27. All products under Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121247 | 2013-03-22 |
| K121256 | 2012-09-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.