AppleInsider StaffBiosense Technologies' uChek system turns Apple's iPhone into a capable urinalysis device, and now the Food and Drug Administration is saying that it may need to clear the medical app lest developers risk violating federal law.
UChek relies on test strips from Siemens and Bayer, and those strips are only approved for visual reading, according to Bloomberg. uChek's app, though, uses the iPhone's camera to analyze the testing strip and return a result for a user.
The FDA has sent a letter to the system's developers, saying that the agency was concerned about uChek's usage and that Biosense should contact the agency to discuss the app.
"We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable, and convenient diagnostics across the world," Biosense's founder told Bloomberg.
Since it is used for diagnostic functions, uChek falls under the purview of the FDA, which has been looking to restructure its regulations in order to handle the increasing presence of iOS devices in the medical field.
"We intend to finalize the guidance this year," an agency spokesperson told Bloomberg. "The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don't work as intended."
uChek is available in the App Store as a free download, and a uChek system is available from the company's site for $40.
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29 Comments
For a sec there I though it was a physical attachment that you directly pee on.
Oops. The Feds are pissed.
I wonder what the target market is for this system. Hospitals and clinics already have commercial testing equipment. If their system did drug testing then I could see a huge market for it, but after reading the web site, apparently it is not for that purpose. Currently available private use drug test cards are about $5 a test.
Interesting app, but I used to work in a hospital. I wonder how often busy staff will go through that long procedure: pasteboard box setup, alignment and all. Most color lab strips can be read with the eye in a few seconds in a patient's room. This seems to take a minute or more just for the test and you can't leave an iPhone lying around waiting to be snitched. That said, if the strip plus app is accurate enough to replace pricey lab tests, it makes sense. If it's just in place of a quick, is there blood/protein in the urine check, it matters less. Also, as a practical matter, a more theft-proof, table-top device that's easier and quicker to setup would be better. Staff could slide the strip in, push a button, and come back few minutes later for the on-screen results. And if the cost savings of going with an iPhone justifies it, that device could use a built-in phone, report the data by Wifi or cellular, and even alarm for out-of-normal results. In a hospital, speed of use matters as much as cost. Staff don't have the time wait around for scans and calculations. --Michael W. Perry, author of Hospital Gowns and Other Embarrassments
In a hospital, speed of use matters as much as cost. Staff don't have the time wait around for scans and calculations.
Well considering that it is recorded digitally may lend itself to integration with a patient management system which could save time and costs.