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iPhone Urinalysis App Draws U.S. Government Scrutiny

The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone into a medical device, designed to read urinalysis test strips that are normally examined by users and compared to a color-coded chart.

With the uChek system, patients can take a picture of the strip with the iPhone's camera and then receive an automated readout of parameters like glucose, urobilinogen, pH, ketone and more. The app also stores results which then can be analyzed over time.

Uchek
Though medical device makers have adopted the iPhone for some measurements like blood glucose monitoring for diabetics, large scale use of smartphones and tablets as a replacement for existing medical devices has yet to take off -- likely due in large part to government regulation of medical devices.

From Bloomberg:
Biosense Technologies Private Ltd.’s uChek system isn’t cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to processes and generate automated results.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.
The uChek kit can be purchased in the US and India for $40, while the uCheck iPhone app is a free download [Direct Link] from the App Store -- though the app can also manually read urine strips from other companies.

Top Rated Comments

(View all)

12 months ago
As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Rating: 19 Positives
12 months ago
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Rating: 17 Positives
12 months ago
Cue class action from consumer group that have number 1'd all over their phone.
Rating: 14 Positives
12 months ago
Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
Rating: 12 Positives
12 months ago
This is front page worthy? Seriously?
Rating: 11 Positives
12 months ago

The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.


Woah, there cowboy!

The govenment doesn't need to use the FDA to tax anything, so you are making no sense. And there are several things that could go wrong here. The camera needs to be working well enough, the app needs to process the image correctly and display the results correctly. The FDA approval process should ensure that uChek has put into place sufficient quality control and verification.

The Tobacco and self-driving car stuff is important stuff, but completely irrelevant... If you are concerned about those, you should be posting comment on stories with some relation to those topics.
Rating: 10 Positives
12 months ago

can't wait to pee on an iphone


R. Kelly would approve
Rating: 8 Positives
12 months ago

The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.



how do you know the app's results are real without any testing or verification?
Rating: 8 Positives
12 months ago

So… Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.

Because the FDA DOES have jurisdiction over medical testing devices. They approve all of those pee-on-a-strip tests for pregnancy/ovulation. They have jurisdiction over home glucose test machines and home blood pressure machines. This is written into their charter. Part of why they exist is to prevent dangerous or at the least ineffective patent medicines and health machines.

From the article

Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not,

The FDA is not demanding the system be pulled, they are asking the manufacturer to explain why this is not the same as the devices they already have jurisdiction over and have to approve.
Rating: 7 Positives
12 months ago

The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.


Or not. It could be that they want to make sure he app is doing its job correctly. Imagine if it gave a wrong result and someone ended up in the hospital. Or dead.
Rating: 7 Positives

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