India-based medical devices firm Biosense Technologies has come under the scrutiny of the US FDA for its recently-launched iPhone app uChek, which allows patients to analyse urine samples.
In a letter, the FDA has asked the company to get approval for the medical app as it is available for US iPhone users.
With the help of mobile app, patients perform tests relating to 25 medical conditions such as liver, kidney and bladder problems, in addition to diabetes and urinary tract infections.
uChek enables users such as diabetics to check their glucose levels by dipping the test strips in urine, following which smartphone's camera enables the system to quickly process and produce automated results.
The urine analyser also aids visual inspection, as well as featuring manual data logging and time-keeping facilities.
uChek system works only with test strips that are manufactured by Siemens and Bayer, which have received FDA clearance for visual reading, but need further approval for automated analysis.
The FDA letter said that any company planning to promote its medical device for analysing, reading and interpreting these dipsticks should get clearance for the complete urinalysis test system, which includes the strip reader and the test strips.
Biosense said it intends to work on the uChek system with the agency in the next few months.
It will also work in the process of appropriately categorising the product as mobile medical app, a new classification for the agency.
The US agency has urged the medical device firm to submit the FDA clearance number for the urine analyser app or submit the reason why it believes that it does not require the clearance in approximately 30 days.