Teco Diagnostics Saliva Alcohol Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111206 FDA 510(k)
- FDA Product Code
- DIC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3040 FDA 510(k)
- Regulation Number
- 862.3040 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Teco Diagnostics Saliva Alcohol Test is a rapid diagnostic device designed for the semi-quantitative detection of ethyl alcohol (ethanol) in human saliva. It employs an enzyme-based method utilizing alcohol dehydrogenase to measure alcohol levels, providing qualitative and semi-quantitative results at predefined cut-off concentrations. This device is classified under the category of alcohol dehydrogenase-specific reagents for ethanol testing in clinical toxicology applications. The test strip features a built-in control line to ensure accuracy and reliability during use.
This device is intended for single-use in point-of-care or clinical settings, such as emergency rooms, law enforcement, or medical facilities requiring rapid alcohol screening. Supplied as a non-sterile, ready-to-use test kit, it does not require special storage conditions beyond protection from extreme temperatures and moisture. The test is not MRI-compatible and is available in various lot-specific reference codes for inventory management. Regulatory clearance under the FDA’s 510(k) pathway (K111206) confirms its substantial equivalence to a predicate device, adhering to U.S. medical device regulations (21 CFR 862.3040)
Frequently asked questions
What is the Teco Diagnostics Saliva Alcohol Test used for?
The Teco Diagnostics Saliva Alcohol Test is designed for the semi-quantitative detection of ethyl alcohol (ethanol) in human saliva. It employs an enzyme-based method with alcohol dehydrogenase to measure alcohol levels, providing qualitative and semi-quantitative results at predefined cut-off concentrations. This device is intended for use in point-of-care or clinical settings, such as emergency rooms, law enforcement, or medical facilities, where rapid alcohol screening is required for clinical toxicology applications.
How is the Teco Diagnostics Saliva Alcohol Test supplied, and what are its storage requirements?
The test is supplied as a non-sterile, ready-to-use test kit. It does not require special storage conditions beyond protection from extreme temperatures and moisture. Since it is designed for single-use, each test should be stored in its original packaging until use to maintain accuracy and reliability.
Is the Teco Diagnostics Saliva Alcohol Test sterile, and can it be reused?
No, the Teco Diagnostics Saliva Alcohol Test is not sterile and is explicitly designed for single-use only. Reusing the test could compromise accuracy and reliability, as the enzyme-based method and control mechanisms are not intended for repeated applications.
What reference codes or lot numbers should I expect when ordering this device?
The Teco Diagnostics Saliva Alcohol Test is available in various lot-specific reference codes for inventory management. These codes include, but are not limited to: 3007606081, 3009238284, 2517506, 3006198300, and others listed in the regulatory records. Always verify the specific lot or reference code with the manufacturer or supplier to ensure compatibility with your needs.
Can the Teco Diagnostics Saliva Alcohol Test be used in an MRI environment?
No, the Teco Diagnostics Saliva Alcohol Test is not MRI-compatible. It should not be used in or near MRI equipment, as the materials or components of the test may react adversely to the magnetic fields or radio waves used in MRI procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alcohol Saliva, PDF TECO DIAGNOSTICS Ki t19O d - Food and Drug Administration, Rapid Tests | Teco Diagnostics, TECO DIAGNOSTICS SALIVA ALCOHOL TEST - Innolitics, Teco Diagnostics Saliva Alcohol Test (19231) - Ethanol (alcohol)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111206 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K111206 24 fields · synced Oct 1, 2026