This is a first. American regulators have sent a letter to India’s Biosense Technologies, a medical device & app making company to see if it complies with food and drug administration standards.
Bloomberg reports that the company’s latest app, uChek, which is used to analyse urine samples isn’t cleared by the FDA. The app, takes a photograph of a urine strip and generates results which can be stored. “Food and Drug Administration and the agency said it wants to know why,” the report said.
The uChek system includes urine strips (dip sticks), a light box called cuboid, and an iPhone app. The report says that the company might have to get clearance for the entire system including the strips (read our full coverage of uChek). In our earlier article on uChek, Myshkin Ingawale, co-Founder of Biosense had commented that the company is engaging with the US FDA on this.
We think it is just a matter of time before it gets FDA approval.
Update: Ingawale told NextBigWhat that the company has registered with the US FDA as a medical device, under the product class “Automated Urinalysis System”. This is a Class 1 device, typically exempt from pre-market notification, he said.
“We are working with the FDA on specifics of our system…I believe strongly in both innovation AND regulation – and that is is the way forward to ensure both affordable access AND quality of care,” said Ingawale.
The urine strips used by the uChek system, are sold by Siemens AG and Bayer AG, and are already FDA approved. What the FDA might be interested in, is the accuracy of the app.
Biosense says that independent studies have confirmed the accuracy of the app to be at par or better than the devices that are currently in use. A study by Nanobios Lab, the laboratory run by the Indian Institute of Technology (Bombay) in April, said
The results suggest equal and more than 95% accuracy with respect to both Dirui’s strips used with the semi-automated urine strip reader and visual correlation.
uChek’s own study finds that its results were accurate with 100% readings within +/- 1 color block of the urine test strip used.
“It may be concluded that the accuracy of the uChek analyzer is comparable to the Uri-Plus 200 and other such commercially available semi automated urinalysis machines,” said the report.
The Mumbai based company, is backed by GSF Accelerator.
The recent Ranbaxy scandal could have forced the US FDA to take a stronger regulatory stance with respect to foreign companies exporting medical equipment and pharmaceuticals to the United States. In one of the most shocking drug scandals of recent times, India’s largest drug maker Ranbaxy pleaded guilty on seven criminal charges which included willful circumvention of laws to sell “adulterate drugs with intent to defraud.” It also did not report facts pertaining to tests on drugs that failed to meet specifications to the US government.