“Breathalyzer Buying Guide: 9 Things You Should Know About Personal Breathalyzers”
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BreathKey Frequently Asked Questions
What is meant when you say that the BreathKey
is "FDA Certified"?
The BreathKey has passed the Food and Drug Administration's 510(k) certification process. This means that the FDA has determined that the BreathKey is "substantially equivalent" to other breathalyzers that are already marketed with FDA approval. Essentially, that means the BreathKey has passed the testing required by the FDA and it does what the product literature says it does. The BreathKey underwent extensive laboratory and field testing in order to get this FDA certification.
510(k) refers to a section of the Food, Drug and Cosmetics Act. The FDA has a submission and control process, wherein particular products, such as safety devices, go through a strict process of evaluation and testing in order to receive FDA approval. Breathalyzers either receive FDA approval or they do not. There is no rating system involved; the criterion is very black and white.
All home breathalyzers sold in the US are required by the FDA to have 510(k) certification, although many that are marketed today are illegally sold without it. So any breathalyzer worth considering should have been certified by the FDA. Then you will be assured that the FDA has made the determination that the breathalyzer operates safely and in a way that is consistent with its claims.
Breathalyzers used by law enforcement require Department of Transportation (DOT) approval. The purpose of DOT approval is to make sure that a breathalyzer meets certain accuracy standards set by the DOT in the event that the breathalyzer results are to be used in a courtroom setting. The DOT is not concerned with consumer safety, which is the purpose of the FDA. Some breathalyzers sold to consumers have DOT approval, but DOT approval does not substitute for FDA certification. So unless a breathalyzer has specifically passed the FDA’s 510(k) certification process, it cannot be legally sold to consumers.
