WASHINGTON — An iPhone application that lets users check levels of blood, protein, and other substances in their urine is the first target of US regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go.
Biosense Technologies Private Ltd.’s uChek system isn’t cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to process and generate automated results.
UChek works with test strips made by Siemens and Bayer, which are approved only for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.
The app needed to run the $40 automated system became available in Apple’s App Store earlier this year after being praised at the technology conference TED2013 in California. The FDA told Biosense the company may need to gain agency clearance for the entire system, including the strips.
‘‘We intend to work very closely with the US FDA over the coming months to ensure that we continue to deliver accurate, affordable, and convenient diagnostics across the world,’’ Abhishek Sen, cofounder of Thane, India-based Biosense, wrote in an e-mail.
Biosense declined to comment further on their communication with the FDA. Representatives from Siemens and Bayer, both based in Germany, didn’t immediately respond to requests for comment.
The FDA for the first time sent a letter to an app maker notifying them of the agency’s concerns about providing an opportunity for Biosense to meet and discuss the issue.
Depending on how a company responds, the FDA may follow up with a warning letter that sets out specific violations of the law that must be addressed immediately, agency spokesman Synim Rivers said.
The FDA letter points to data submitted for a urine analyzer made by Acon Laboratories as an example of the information sought from Biosense. Acon, based in San Diego, submitted a 510(k) application, which is the least stringent of FDA device approval pathways that doesn’t typically warrant clinical trials.