The FDA is investigating an app that lets users do self-administered urine tests to check for conditions such as diabetes.
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. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).
Uchek, which launched this past winter, boasts that it gives users the ability to analyze their own urine samples and check for medical conditions without having to go to the doctor. Like at the doctor’s office, a user pees into a cup and then dips a test strip into the cup. The strip will change color and users can match the strip with the app to analyze the results based on a color system. (Via The Los Angeles Times).