The Analytical Scientist / Issues / 2013 / Jul / Smarter Administration
Clinical News and Research Technology

Smarter Administration

The talk of TED but a few months ago, uChek, an iPhone-based urinalysis system, came almost immediately under fire from the FDA. There’s an app(roval) for that…

By Rich Whitworth 07/23/2013 1 min read

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“It has come to our attention that you are currently marketing the uChek Urine analyzer […]” began a foreboding letter from the US Food and Drug Administration (FDA) (1) to Myshkin Ingawale, co-founder of Biosense Technologies, India. Given that the iPhone, app, and urine dipsticks all come together for the qualitative and semi-quantitative determination of urine parameters (glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity), the FDA considers uChek a device within its jurisdiction. “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),” warned the letter.

Ingawale is no stranger to TED or “devices”. Back in February 2012, he unveiled another portable (non-iPhone-based) device to noninvasively measure the hemoglobin content of blood using photoplethysmography and reflectance spectroscopy. The aim? To “democratize healthcare” by preventing unnecessary deaths caused by anemia through simple, affordable tests placed in the hands of the health workers that need them. Things have gone very quiet on that project – several research papers on the same subject dating back to 2002 could indicate patent problems (2) – but it’s hard to bemoan such noble intentions after watching his TED Talk.

Going back to his latest uChek system, the app uses an iPhone camera to compare the dipstick results with a color mat (for lighting normalization), and provides information to help users understand the results – whether it be an indication of a kidney problem, urinary tract infection, hypertension, or diabetes complications. Certainly, plenty of scope to turn all iPhone users into hypochondriacs.

Ingawale appears to have a keen eye on the developing world, so the FDA letter is unlikely to dampen his entrepreneurial spirit.

References

  1. 1.usa.gov/Z2ghow
  2. T. Aldrich et al., “Length-normalized pulse photoplethysmography: a noninvasive method to measure blood hemoglobin,” Ann.  Biomed. Eng. 30(10):1291-8 (2002).

About the Author(s)

Rich Whitworth

Rich Whitworth completed his studies in medical biochemistry at the University of Leicester, UK, in 1998. To cut a long story short, he escaped to Tokyo to spend five years working for the largest English language publisher in Japan. "Carving out a career in the megalopolis that is Tokyo changed my outlook forever. When seeing life through such a kaleidoscopic lens, it's hard not to get truly caught up in the moment." On returning to the UK, after a few false starts with grey, corporate publishers, Rich was snapped up by Texere Publishing, where he spearheaded the editorial development of The Analytical Scientist. "I feel honored to be part of the close-knit team that forged The Analytical Scientist – we've created a very fresh and forward-thinking publication." Rich is now also Content Director of Texere Publishing, the company behind The Analytical Scientist.

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