FDA Investigating Urine Analysis App
The FDA is investigating an app that lets users do self-administered urine tests to check for conditions such as diabetes.
In a letter written to Biosense Technologies Private Limited, the creator of uChek Urine analyzer, the FDA asks for proof of FDA clearances for the app. Here is an excerpt from the letter:
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 these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system.
WORK SMARTER - LEARN, GROW AND BE INSPIRED.
Subscribe today!
To Read the Full Story Become an Adweek+ Subscriber
Already a member? Sign in