The US Food and Drug Administration (FDA) has asked GSF India-backed Biosense Technologies‘ iPhone based urine analysis app uChek to get a clearance for the app by the agency, reports Bloomberg, adding that this is the first time FDA has sent a letter to mobile based medical apps maker.
For the uninitiated, uChek app is an urine analysis iOS app which can be used to test for 25 different medical conditions including diabetes, kidney, liver and bladder problems, pre-eclampsia and hypertension, and urinary tract infections. While the app is available as a free download on the Indian and the US app store, one needs to also purchase a uChek kit and urine dipsticks separately to conduct urine analysis through the app. The uChek kit is currently available for Rs 1,999 in India and $40 in the US, while the urine dipsticks is available at different price ranges starting at Rs 290 for 50 strips and going up to Rs 1596 for 100 strips.
In a letter to Biosense, FDA says that the uChek Urine analyzer has been approved since it appears to meet the definition of a device as defined in section 201(h) of the Federal Food Drug and Cosmetic Act, however the uChek dipsticks which are made by Siemens and Bayer are approved only for direct visual reading and not automated analysis, due to which these dipsticks will require a new clearance for automated analysis.
FDA says that it is currently unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer and has asked the company to provide the FDA clearance number for the uChek Urine analyzer or else provide reasons as to why the urine analyser doesn’t need an additional clearance, if the company believes so. In a emailed response to the publication, Biosense co-founder Abhishek Sen has however said that they intend to work closely with the FDA over the forthcoming months.
Its also worth noting that the uChek website says the app can also be used only for external testing as advised by a healthcare professional. Earlier this month, Biosense Director Myshkin Ingawale had told Medianama that this disclaimer was put out to avoid self-medication and to comply with U.S laws, although anybody with a smartphone can use this app on their own.
No Guidelines For Mobile Medical Apps? Interestingly, although FDA has asked for an explanation, it doesn’t seem to have any guidelines for mobile based medical apps in place yet. Citing FDA spokesperson Synim Rivers, the report says that FDA has proposed a regulatory approach which limits its control to smaller subset of mobile based medical applications which can double up as medical devices and plans to finalize the guidelines by this year.
Other players: While we are not familiar of any Indian company offering a similar solution, Denmark-based LineHQ is developing a similar iOS app called Piddle, which aims to offer urine analysis through test strips. However, it hasn’t launched the app yet.