This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the agency.
Biosense’s uChek system includes an iPhone app and a color-coded mat. It works with a handful of already FDA cleared test strips from Siemens and Bayer. The uChek user puts the test strip on the mat — which contains color samples to normalize lighting conditions — and then snaps a picture with their smartphone camera. The app analyzes the strip colors against the swatches on the mat, and returns data about glucose, protein, ketone levels, and more in the sample as well as diseases detected. The user can save readings and track data over time.
"Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading," James Woods, a deputy director with the FDA, politely stated in the letter. "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)."
On Biosense's FAQ section of its website, the company explains that:
"Yes, uChek is a medical device. It is for In Vitro Diagnostic Use only and only to be used by or on the recommendation of a qualified healthcare professional. Biosense Technologies Pvt Ltd, the manufacturer of the uChek urine analyzer is a FDA registered facility and the uChek urine analyzer is a medical device registered under Product Code KQO, and as per regulation 862.2900 of the FDA."
In his letter Woods goes on to explain that the FDA has reviewed its database of cleared and registered medical devices and could not find one for uChek. He then asks Biosense to provide the FDA with appropriate information or to provide the FDA with an argument for why it does not require registration or clearance. The company has 30 days to respond.
Woods also points Biosense to a summary clearance document for a similar medical device that analyzes urine test strips. As of this writing the uChek app is still available in Apple's AppStore.
uChek gained a considerable following after Biosense Technologies Co-Founder Myshkin Ingawale demonstrated the app during a TED talk earlier this year. Since then the application has received considerable press attention and, notably, was mentioned as an example of an app the FDA might be failing to regulate appropriately during the FDA medical app congressional hearings this past February.
If the letter from the FDA does result in Apple removing uChek from the AppStore (even if it's a temporary exile), the urinalysis app would be one of the few known examples of apps to be taken down because of such an action. Most famously, MIM Software's Mobile MIM imaging app, which was demo'd onstage at Apple's 2008 World Wide Developers Conference -- the one that kicked off the launch of the AppStore, was removed from the AppStore in the months to follow because the FDA believed it might need clearance as a medical device. It ended up taking MIM two years to secure clearance.
While the FDA clearance process for mobile medical apps is still far from efficient, the agency has given the issue much more attention in recent years. The fate of Bionsense's urinanalysis app will serve as an important bellweather for the current regulatory climate for mobile medical apps.
For more on FDA regulation of mobile medical apps, head over to our Research Store for the MobiHealthNews report: 75 FDA Regulated Mobile Medical Apps.