May 27, 2013
FDA Seeks Regulatory Approval For Urine Analysis App
Michael Harper for redOrbit.com — Your Universe Online
Myshkin Ingawale wants to give people the power of information when it comes to their bodies. Earlier this year he and the company he cofounded, Biosense Technologies, launched a urine analysis app for iPhone called uChek, which snaps a picture of a urine analysis strip as it looks for potential trouble up ahead.Now the FDA is looking further into the issue, claiming the app first needs to obtain regulatory approval before it can be marketed. The idea of using an app to check urine for signs of blood or urinary tract infections is a new one. This could explain why the FDA sent their “It Has Come to Our Attention” letter to Biosense; the analysis strips used by the uChek app are FDA-approved and have been used for many years, yet the technology to scan these strips must now be approved as well, argues the FDA.
For $40, customers can pick up the uChek kit directly from Biosense which includes a sampling of several brands of FDA-approved testing strips and a ColorMat with which to match the colors returned on the strips. The uChek app is available for .99 cents in Apple's App Store.
Users can insert the dipstick testing strips into a sample of their urine then place it on the ColorMat. The uChek app is then used to snap a picture of this dipstick and perform a more in-depth analysis of the strip as opposed to matching colors with suggested diagnoses.
In his letter to Ingawale, FDA Deputy Director James L. Woods says though the dipsticks offered by Biosense are FDA-approved for urine analysis by visual reading, the introduction of a scanning process warrants further regulation.
“Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader,” writes Woods.
“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)," he added.
Ingawale has issued a press statement to the LA Times, saying Biosense plans to cooperate with the FDA.
"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," said Ingawale. "Apart from this, we will not be commenting on any aspect of our communication with the U.S. FDA."
In their letter to Biosense, the FDA says the Indian medical company has 30 business days in which to seek approval from the administration or explain why the app doesn´t need any special clearance.
Ingawale showed off his app during a TED conference earlier this year, touting the system´s ability to offer a sophisticated reading cheaply and easily.
“The idea is to get people closer to their own information,” said Ingawale during his TED talk. “I want people to better understand what is going on with their bodies.”