The company that developed the app, “Biosense Technologies”, is the first to be under scrutiny by the FDA (Food and Drug Administration) about a mobile application.
According to the letter, the device is “intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips for the qualitative and semi-quantitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.”
The FDA states that based on its description, it is considered to be a device as it carries out an automated analysis of urine strips, according to section 201(h), subsequently requiring FDA approval.
The app has the same working principle and is substantially equivalent to most other semi-automated urine analyzer machines. When people dip their urinalysis reagent strip (“dipstick”) in urine the paper will change color, the color change indicates the concentration of different analytes in the urine. Using a smartphone to take a photo of the strip, the “uChek Urine analyzer” is able to automatically make an analysis and make a complete evaluation.
Video of how the App works
FDA Deputy Director James Woods said:
“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).”
Biosense co-founders Abhishek Sen and Myshkin Ingawale, said: “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. Apart from this, we will not be commenting on any aspect of our communication with the U.S. FDA.”
The FDA said that the company has up to 30 business days to seek approval. If the company believes that it does not have to seek clearance, it should provide the FDA with the basis for that determination.
Written by Joseph Nordqvist