The Food and Drug Administration has started cracking down on medical apps and it looks like uChek by Biosense Technologies Pvt Ltd is the first on the chopping block.
uChek does either an automated or manual urinalysis to determine liver and kidney function, bacteruria, acid-base balance, blood sugar, and carbohydrate metabolism.
The FDA has sent a letter to the developers, asking why they didn’t seek approval for the app before it was released. Biosense was given 30 days to prove it already has FDA approval, or to explain why the app doesn’t need approval in the first place.
Basically, the FDA’s issue isn’t whether the app works; there’s no argument there. Instead, the Agency says that the strips that the app reads were designed to be read by the human eye; when the app scans the strips, it turns the device into an “automated strip reader,” which is part of a system that needs FDA approval..
As of May 25, 2013, the app was still available on iTunes (here) and can help detect many diseases like pre-eclampsia, diabetes, and urinary tract infection.
