Food and Drug Administration Sends Letter to Biosense Technologies Regarding Urinalysis Phone App
After months of complaints from experts that the uCheck app is a medical device that failed to seek FDA approval, the U.S. Food and Drug Administration send a letter this week to Biosense Technologies, the maker of uChek smartphone-enabled unrinanalysis system instructing it to seek 510(k) clearance of its mobile medical application or to convince the FDA that such clearance is not necessary.
James Woods a deputy director with the FDA, stated in the letter, “Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading….Since your app allows a mobile phone to analyze the dipsticks the phone and device as a whole functions as an automated strip reader. When those strips are read by an automated strip reader, the dipsticks require new clearance as part of the test system.” The letter concludes that any company intending to promote such a device needs to obtain clearance for the entire urinalysis test system.
More information available at: FDA wants to know why uChek app doesn’t have clearance