According to the FDA: The uChek Urine analyzer appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.
The FDA recently issued an inquiry letter to Biosense Technologies Private Limited, saying:
We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer. We request that you provide us with the FDA clearance number for the uChek Urine analyzer. If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination. Please provide the requested information within thirty (30) business days.
This may be the first example of the FDA issuing a letter regarding a mobile medical app/device. Will we see other examples in 2013?