Bringing this iPhone breathalyzer to market was a sobering affair

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Photo: Jim Merithew/Cult of Mac
Keith Nothacker fought long and hard to bring his BACtrack breathalyzers to boozers everywhere. Photo: Jim Merithew/Cult of Mac
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LAS VEGAS — Keith Nothacker is living proof that persistence pays off.

Cult_of_Mac_CES_2015 Nothacker is here at the giant International CES gadget show to introduce a key-size version of his pocket breathalyzer — the first personal, police-grade breathalyzer approved by the Food and Drug Administration. Connected by bluetooth to your iPhone, a quick puff into the $49 BACtrack Vio will tell you instantly if you’re too juiced to drive — or take part in any other activity best done sober.

But 13 years ago, Nothacker was fighting the FDA to bring the device to market.

He came up with the idea for a consumer breathalyzer when he was a college student. Like most students, he partied hard. Nobody had any clue how drunk they were or if they were safe to drive. DUIs are an expensive nightmare, of course, and Nothacker wondered why only police officers had access to breathalyzers. He set out to make the first such device for ordinary people.

It wasn’t an easy task. He needed to find the key component that measures how much alcohol is in a person’s breath. This was before Google, and it took weeks to figure out. He persistently called hundreds of manufacturers until he found a supplier in Asia.

Then he spent all his money to ship the hardware to the United States. However, the suspicious FDA held up the shipment in Alaska because they’d never seen anything like it.

Nothacker was broke, and in quiet desperation, he called the FDA every day about the shipment.

“I told them, ‘You can’t steal my product.'”

He was so persistent, the FDA assigned a special investigator to his case. The special investigator determined that the breathalyzer was a personal-use medical device that required an FDA 510(k), a special certification for medical device manufacturers. That meant Nothacker had to conduct a medical user study.

With no money, he conducted the testing on his own. He persuaded 100 people to drink alcohol and then read some instructions. The testers than had to tell him how easy it was to read and comprehend the instructions, while he tested their breath for blood alcohol.

He submitted his study to the FDA, which approved BACtrack to be the first company to sell personal breathalyzers.

Photo: Jim Merithew/Cult of Mac
The BACtrack Vio would be right at home on your keychain. Photo: Jim Merithew/Cult of Mac

Launched two years ago, the BACtrack Mobile became the world’s first smartphone breathalyzer. It’s small, portable and easy-to-use, yet delivers police-grade quality. It’s now available in more than 10,000 retail locations, including Target, Walgreens, Best Buy and Costco.

This year at CES, Nothacker unveiled the BACtrack Vio, a keychain version of the BACtrack Mobile that costs $49.99. Nothacker said having it on your keychain with your car keys is a convenient reminder to blow before you go.

“There’s no excuse not to use it because it’s right there,” he said.

I totally agree, and I had a lot of fun playing with the Vio at the show — after a cocktail, of course. The things I have to do for work.

The BACtrack Vio is dead-simple to use. It wirelessly connects to an iPhone via Bluetooth. Inside the app, you first have to guess what you think your blood-alcohol level will be. While you are guessing, the breathalyzer burns off any residual alcohol from a previous test. There’s also an educational component: Guessing how drunk you are and then seeing the real numbers can be a sobering surprise.

I took a deep breath and blew into the device. Seconds later, it displayed my blood-alcohol level on the iPhone’s screen. It was low, but if I’d been over the legal limit, the app would have told me how long I would need to wait before I could get behind the wheel.

Perhaps most importantly, the app tracks all your previous results. That way you can see if there are any drinking patterns you should be concerned about. Bottoms up!