iPhone urinalysis app draws scrutiny from FDA
Biosense Technologies' uChek system turns Apple's iPhone into a capable urinalysis device, and now the Food and Drug Administration is saying that it may need to clear the medical app lest developers risk violating federal law.
UChek relies on test strips from Siemens and Bayer, and those strips are only approved for visual reading, according to Bloomberg. uChek's app, though, uses the iPhone's camera to analyze the testing strip and return a result for a user.
The FDA has sent a letter to the system's developers, saying that the agency was concerned about uChek's usage and that Biosense should contact the agency to discuss the app.
"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," Biosense's founder told Bloomberg.
Since it is used for diagnostic functions, uChek falls under the purview of the FDA, which has been looking to restructure its regulations in order to handle the increasing presence of iOS devices in the medical field.
"We intend to finalize the guidance this year," an agency spokesperson told Bloomberg. "The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don't work as intended."
uChek is available in the App Store as a free download, and a uChek system is available from the company's site for $40.
UChek relies on test strips from Siemens and Bayer, and those strips are only approved for visual reading, according to Bloomberg. uChek's app, though, uses the iPhone's camera to analyze the testing strip and return a result for a user.
The FDA has sent a letter to the system's developers, saying that the agency was concerned about uChek's usage and that Biosense should contact the agency to discuss the app.
"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," Biosense's founder told Bloomberg.
Since it is used for diagnostic functions, uChek falls under the purview of the FDA, which has been looking to restructure its regulations in order to handle the increasing presence of iOS devices in the medical field.
"We intend to finalize the guidance this year," an agency spokesperson told Bloomberg. "The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don't work as intended."
uChek is available in the App Store as a free download, and a uChek system is available from the company's site for $40.
Comments
I wonder what the target market is for this system. Hospitals and clinics already have commercial testing equipment. If their system did drug testing then I could see a huge market for it, but after reading the web site, apparently it is not for that purpose. Currently available private use drug test cards are about $5 a test.
That said, if the strip plus app is accurate enough to replace pricey lab tests, it makes sense. If it's just in place of a quick, is there blood/protein in the urine check, it matters less.
Also, as a practical matter, a more theft-proof, table-top device that's easier and quicker to setup would be better. Staff could slide the strip in, push a button, and come back few minutes later for the on-screen results. And if the cost savings of going with an iPhone justifies it, that device could use a built-in phone, report the data by Wifi or cellular, and even alarm for out-of-normal results.
In a hospital, speed of use matters as much as cost. Staff don't have the time wait around for scans and calculations.
--Michael W. Perry, author of Hospital Gowns and Other Embarrassments
Quote:
Originally Posted by Inkling
In a hospital, speed of use matters as much as cost. Staff don't have the time wait around for scans and calculations.
Well considering that it is recorded digitally may lend itself to integration with a patient management system which could save time and costs.
iPod with camera instead of iPhone should work too right?
If I understand the video - the point of the setup is to standardize the exposure etc - and that the test strip itself takes a number of minutes to read - not that the app takes minutes to process - which means a person would have to watch a clock and make observations over a period of time - which are subject to variations in lighting and subjective interpretation of comparing colors - could also be affected by the person's ability to distinguish shades of color.
Could see an iPod somehow attached to a cart used for this purpose to prevent it walking off. also having the (video or photos?) taken at defined intervals should reduce errors in results produced.
Quote:
Originally Posted by mstone
I wonder what the target market is for this system. Hospitals and clinics already have commercial testing equipment. If their system did drug testing then I could see a huge market for it, but after reading the web site, apparently it is not for that purpose. Currently available private use drug test cards are about $5 a test.
mstone, Many patients, including myself, must regularly check their own urine using these sorts of dipsticks. Several times per day.
Just today I was looking for an app merely to record my results on, before deciding that my iPhone's "notepad" app was all I needed. However, the type of app described in this article would be extremely useful, especially if it included a timing alarm, since the readings must be taken at a 30 or 60 second interval, depending.
Now, as a scientist, I will say that the obvious problem with this app is the limitations on it's ability to correlate a color shade with a standard. Typically, these test strips are supplied with a reference card which the user compares the color of the dipstick with the color on the card. The color graduations can be subtle in hue and brightness. The reference card must be printed using an ink and paper system that is proven to be stable through the expiration date of the test strip lot number. The human eye is able to automatically "color balance" objects to compensate for the ambient light (such as tungsten or fluorescent lamps, or sunshine, etc.) Because the eye is comparing the stick to a reference that is illuminated by exactly the same light source, the comparison is valid.
I have not used the UChek device, but it is POSSIBLE that it merely photographs the dipstick, and electronically compares the colors it sees to an internal standard. Thus, the snapshot of the dipstick will reflect colors under the influence of a lighting system not accounted for by the Uchek device, and thus yield incorrect results. Furthermore, I have noted that different brands of these kits do not use exactly the same shades on their reference cards, nor at the same concentration increments. So if the patient is using a different brand than supported by the Uchek device, the results will be incorrect. Because the diagnostic medical nature of these kits can be critically important in disease management, such arbitrary variation is unacceptable. Of course, it is also POSSIBLE that the Uchek device uses the iPhone to photograph both the dipstick and the users reference card, simultaneously, and also allows the user to assign the values to the colors on the reference card. Unfortunately, it is not so easy to hold a dipstick, a reference card (often glued to the test strip bottle), and also manage the iPhone to take a photograph, with only two hands. Furthermore, close-up photography is subject to incidental shadows and non-uniformities in brightness, even when a flash is used, and so the result COULD still be inaccurate.
HOWEVER, if the makers of Uchek can satisfy the FDA on these and other aspects which I may not have thought of, this would be an excellent aid to my ongoing regimen.
I am not a physician, nor affiliated with any medical test kit manufacturer, and the statements above are my own opinions only.
Having now visited the Uchek website, I see that they do photograph a color standard at the same time as the dipstick, which is terrific. Many teststrips are not solely for visual scoring, and can be used by hospitals etc. with a high-end machine. It appears the Uchek system is trying to provide that sort of scoring system for the home user. Awesome! I still wonder about light-leakage around the edges of the photography box, and the ability to correlate the Uchek color panel with various brands of color panels. But it does sound very promising. I hope the FDA finds that this is an acceptable medical device!
Quote:
Originally Posted by MyDogHasFleas
Was going to post "cue piss jokes in 3...2...1..." But I see I'm already too late..
Tee hee hee.
That's only said by those that think it's all a pissing contest.
Quote:
Originally Posted by TeaEarleGreyHot
mstone, Many patients, including myself, must regularly check their own urine using these sorts of dipsticks. Several times per day.
I have not used the UChek device, but [...]
Check out the website. It explains a lot, and answers some of your questions.
Quote:
Originally Posted by SolipsismX
This gets my vote for the number one iPhone app.
It's a short field. The Number Two app is pure shit.
Quote:
Originally Posted by SolipsismX
This gets my vote for the number one iPhone app.
Can't wait for the number 2 app. I hear it exports ... a user log.
My cousin has a chronic illness for which there is a safe and effective treatment, however my cousin is made to suffer because the cost of getting FDA approval for this drug, exceeds the market value of it.
The FDA makes all drugs for non-billion dollar a year illnesses cost-prohibitive, and thousands of people die, and millions more suffer every year as a result.