The FDA, in what is believed to be the first action of its kind, has written to Biosense Technologies in Mountain View, Calif., informing the company it must seek regulatory approval for its app because the urine test strips it relies on are approved for visual inspection but not for automated analysis, the Los Angeles Times reported Friday.
The uChek app, available on Apple iOS devices, allows people with diabetes and other medical conditions to track their health by dipping test strips into their urine then taking a photo of the strip when dry to let the app determine the levels of various substances in the body.
However, the strips made by Siemens and Bayer are intended to be used by medical professionals doing a direct visual inspection, the FDA said.
"When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system," FDA Deputy Director James Woods wrote in the letter. "Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks needs to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together)."
Biosense has 30 days to seek approval or explain why the app does not require the described clearance, the FDA said.
On its website, uChek says the app was designed in India with the goal of making urine tests more comfortable for people, the Times reported.