There is an app for iPhone users that will test your urine and give you information regarding your health. A recent issue has emerged, however, in that the FDA is now asking the makers of the app why they did not seek approval from the agency prior to releasing the app. The app is called uChek, and it analyzes photos of urine samples to give users health information quickly. The creator, Biosense, has been told by the FDA that they have thirty days to get approval, or else they must show why they do not need it.
The app tests for various elements in the user’s urine, including an ability to test blood sugar in diabetics. The FDA is arguing that when the app scans diabetic test strips that it is in fact operating as an “automated strip reader.” In short, the argument is that this capability theoretically makes the device a medical testing system, and therefore needs FDA approval.