In what’s believed to be the first letter of its kind, the FDA wrote to Biosense Technologies on Tuesday that the Mountain View, Calif., company needs regulatory approval for its app because the urine test strips it relies on are approved for visual inspection, but not for automated analysis.
Available on Apple devices, the uChek app can be used by people with diabetes and other medical conditions to track their health. Users dip test strips into their urine. Once the strips change color, the user snaps a photo and the app determines the levels of various substances in the body. The app’s key innovation is a color mat that’s placed under the strip when taking the picture. The mat serves as a baseline for the analyzer, allowing it to normalize for different lighting conditions. But the strips made by Siemens and Bayer are typically used by medical professionals doing a direct visual inspection.