Breathalyzer - Consumer Use

Consumer Use

There are many models of consumer or personal breath alcohol testers on the market. These hand-held devices are generally less expensive than the devices used by law enforcement. Most retail consumer breath testers use semiconductor-based sensing technology, which is less expensive, less accurate, and less reliable than fuel cell and infrared devices.

All breath alcohol testers sold to consumers in the United States are required to be certified by the Food and Drug Administration, while those used by law enforcement must be approved by the Department of Transportation's National Highway Traffic Safety Administration.

Manufacturers of over-the-counter consumer breath analyzers must submit an FDA 510(k) Premarket Clearance to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a) (3)) that is not subject to Premarket Approval (PMA). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The devices are cleared as "screeners" which means they have met the requirements used by the FDA for detecting the presence of alcohol in the breath. Screener certification does not mean that the device can measure breath alcohol content accurately. Many breath analyzers cleared by the FDA are very inaccurate when it comes to BAC measurement. No semiconductor device has ever been approved for evidential use (to stand-up in a court of law) by any State Law Enforcement Agencies or the U.S. Department of Transportation.

Public Breathalyzers are starting to become a popular method for consumers to test themselves at the source of alcohol consumption. They are now able to be found in almost any type of licensed business. Canadian Breath Analyzer Company and ACS Corporation manufacture and distribute two separate and competing fuel cell models for public use. Canadian Breath Analyzer's unit utilizes a electrochemical fuel cell sensor which is the latest representation of public and mobile scanner technology. Fuel Cells are more expensive and also much more reliable than their semiconductor counterparts. CBA Company's unit is the CBA-FC-Multi and ACS Corp manufactures the Alcolab. These units are tested by the R.C.M.P. and endorsed to be as accurate as their handheld, roadside scanners.

In France, possession of such a device is a legal obligation from 1 July 2012. All drivers of terrestrial motor vehicles (with the exception of mopeds) must be in possession of an unexpired device, and be able to show that it is immediately available for use. Drivers of vehicles that are equipped with an electronic immobilizer breathalyser are exempt from this requirement. Failure to carry a breathalyzer becomes a punishable offence from 1 November 2012. To be in compliance with this decree, the breathalyzer must conform to NF (NFX 20702).