“An iPhone application that lets users check levels of blood, protein and other substances in their urine is the first target of U.S. regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go,” reports Bloomberg (here). The app is uChek and it is free — but you have to buy the test strips and the special “Cuboid” box that positions the iPhone’s built-in camera over the test strip (see the video below).
FDA sent the developers, Biosense Technologies Private Limited, a “It Has Come to Our Attention Letter,” which is a species of FDA communication not previously known by experts like Eye On FDA blogger Marke Senak, who said “in the wake of issuing its Draft Guidance on Mobile Medical Applications, FDA has shed further light on its regulation over medical apps with this letter” (here).
UChek works with test strips made by Siemens and Bayer, which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. You can find the FDA letter (here).
This app sounded familiar to me because it was referred to in a March 20, 2013, House Energy and Commerce Subcommittee on Communications and Technology hearing. The session was titled “Health Information Technologies: Harnessing Wireless Innovation.” In testimony at that hearing, Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition, described a urine analysis mobile app that illustrates why the mobile health app industry needs more consistent FDA regulation. I am sure he was referring to uChek. Thompson pointed out that the app declared itself NOT to be a medical device. “If only it were that simple,” said Thompson. Listen:
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Note: the currently-available version of uChek DOES declare that it is a medical device: “The uChek system consisting of the uChek color mat. (sic) the Cuboid together with the uChek mobile application is a medical device that simplifies urine analysis.” Perhaps this version of the disclaimer was revised after Biosense received the FDA letter.
So, how did the FDA “become aware” of this app? Well, Christy Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological Health at the Food and Drug Administration, also testified at that hearing. Perhaps she had an aside with Thompson and learned the name of the app from him. It’s doubtful that the FDA learned about this app from attending the TED2013 conference in February, 2013, where it “made quite a stir.”
Here’s the video — including magic show gestures and music — demonstrating how to use the uChek app:
