FDA says urinalysis app meets definition of a device, needs clearance
A smartphone app that allows people to conduct their own urine analysis using conventional dipsticks is under scrutiny by the U.S. Food and Drug Administration. In a recent letter to India-based Biosense Technologies Private Limited, developer of the uChek Urine analyzer, the FDA has given the company 30 days to submit in writing an explanation as to why their product should not be required to obtain 510(k) clearance.
"It has come to our attention that you are currently marketing the uChek Urine analyzer, which 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," wrote James Woods, the FDA's Deputy Director of Patient Safety and Product Quality in the Office of In Vitro Diagnostics and Radiological Health, in the letter to Biosense Technologies co-founder Myshkin Ingawale. "The uChek Urine analyzer appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."
Designed to better manage diseases like diabetes, urinary tract infections and pre-eclampsia, the app analyzes urine for the presence of up to 10 biomarkers including glucose, protein, ketones, blood, pH, specific gravity, urobilinogen, bilirubin, leukocytes and nitrites. The uChek Urine analyzer uses a smartphone's camera to take photos of chemical strips that are dipped in a urine sample. The app then compares them to a color-coded map and within a few seconds reports the results.
"Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader," argued the FDA in its letter. "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)."
According to a recent article, in initial testing of 1,200 samples, the app delivered more accurate results than humans looking at the color strips by eye. Used with the iPhone 4, 4s and 5, the article states that the uChek Urine analyzer is currently undergoing testing in a Mumbai, India hospital and making its way through the Apple approval process. An Android version is also planned but it will take longer to develop given all the different types of cameras in Android smartphones.
To learn more:
- read the FDA letter
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