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Why the FDA Took the Piss Out of uChek, a Urine Analysis App

Hackers waiting to see if you're diabetic are going to have to wait.

It took no time at all for people to figure out that iPhones are great for sending pictures of one’s genitals, but finding medical applications for the smart phone takes a little longer. Seems intuitive enough; after all, a dick pic can only delay your political career, but anaphylactic shock can kill you. So it should come as no surprise that the Food and Drug Administration thinks an iPhone app that purports to analyze urine samples needs their approval.


People with diabetes who want to check the amount of glucose in their urine can download uChek to their iPhone or iPad. After a “mid-stream collection,” a urine test strip, or dipstick, is dipped into the sample. After a few minutes colors appear to reflect the presence of certain compounds. You then photograph the test strip with the iThing’s camera and the app then compares the colors and allows you to email the results, store them or even chart them over time.

What’s interesting is that the FDA says that using an app like uChek to read an already-FDA-approved urine analysis strip changes the components into a test system, subject to their approval. It’s not what you’re reading, but how, according to the FDA.
In a letter to Biosense Technologies, the makers of uChek, the FDA said, “since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader.” While Fruit Ninja slips under their radar, the urine analysis “device” of phone, app, and dipstick needs to be cleared by the FDA. There are literally thousands of apps in the medical category in the iTunes store, and just as many in health and fitness. Some have already shown positive results, like the colon cleanse-preparation app. FDA approval can take years, and the agency doesn’t want to get in the way of positive or (more often) innocuous innovation.

In an email to Bloomberg, FDA spokeswoman Synim Rivers said, “The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don't work as intended.” In the letter to Biosense, the FDA included an example of an approved, similar device that analyzes urine test strips made by Acon Laboratories. The quickest pathway to FDA approval is finding such a “predicate device” and comparing the new one to it, sparing the manufacturer the time and money required for clinical trials. There’s a photo that’s been going around that has a ton of electronics—two cameras, a Walkman, a laptop, a watch, etc—under the header 1993, and below it, a picture of an iPhone under the header 2013. Soon you’ll be able to add a bulky urine test strip analyzer to that top photo; however there is a trade off. Next time someone whips out their iPhone to Instagram their meal, you’ll have to wonder where that thing has been.