iPhone Urinalysis App Draws U.S. Government Scrutiny

[kingtj]

Seems like there's a line in the sand someplace ....

I'm personally not much of a fan of the FDA. I think it's an organization with, perhaps, initially good intentions, but one which has turned into just another political machine. Some of the foods and drugs getting FDA approval are a joke, and many potentially life-saving drugs never get to be used thanks to their slow approval process, or refusal to accept something as legitimate.

How many people have died taking drugs that initially had FDA approval after "extensive testing"? Quite a few!

Personally, I don't think the real qualifier should be "medically diagnostic", unless we want to define that term to mean "used in a medical setting". If this device was going to be approved for use an actual doctor's office or hospital -- fine. Demand it meets certain standards for accuracy.

But anyone buying this off the shelf and using it at home? It might be a diagnostic tool -- but so is researching one's symptoms on the Internet. Just require a warning label on the box telling people to see a professional if they have real medical concerns stemming from the results the device gave, and leave it at that.

From the BioSense website:

The uChek system may be used for semi-quantitative and qualitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria.

uChek is a medical device*. For in vitro diagnostic use only, on advice of healthcare professional.

and

The uChek urine analyzer is a U.S. FDA Class I medical device, product classification "Automated Urinalysis System"

Class I includes the following (from a Congressional Research Service report):

Class I devices are those under current law for which general controls “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.”24 Many Class I devices are exempt from the premarket notification and/or the QSR requirements, though they still have to comply with the other general controls. A device is exempt if FDA determines that it presents a low risk of illness or injury to patients.

Whether it presents a low risk is open to debate (personally, I think that the risk is at least moderate), but to contend that it's not "medically diagnostic" is absurd.

 

[Lost Rider]

Amazing how many folks (pro photog?...) commenting on the white balance or other light sources with concerns for reliability failed to pay attention to the photo in the OP or look at the companies website for two seconds.


That's a light box.

Here's how it works:

http://www.uchek.in/shop.html



Seems like the company has a very reliable method to insure consistent control of the lighting for photos in the test.


I think it's neat to see "thinking out of the box" applications using an iPhone being developed, even if the solution was "inside the box" thinking.

 

[peterdevries]

Amazing how many folks (pro photog?...) commenting on the white balance or other light sources with concerns for reliability failed to pay attention to the photo in the OP or look at the companies website for two seconds.

The problem is not with white balance or measurement capabilities of the iPhone. The problem is the fact that this system advocates the use of urine strips for diagnostic purposes, while for many diseases systems are available with superior accuracy.

It is a step back presented as a new development in healthcare.

 

[LordJohnWhorfin]

Outrageous

From the manufacturer's own admission, this is a medical device intended for diagnostic. As such, they are not allowed to market it without first getting FDA approval. That's all there is to it, and as a medical device supplier they should have known better.
To the teabaggers who claim this is just a shakedown by big government: last year a compounding pharmacy schemed to bypass FDA control and supervision producing large scale methyl prednisolone injectables. Without FDA oversight, they got greedy and sloppy, and ended up shipping "sterile" product that was contaminated by a fungus and was injected into the spine of patients. Over a hundred people were infected and ended up with an excruciating painful, debilitating, incurable and lethal infection. Still want to get rid of the FDA? Dimwits.

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The problem is not with white balance or measurement capabilities of the iPhone. The problem is the fact that this system advocates the use of urine strips for diagnostic purposes, while for many diseases systems are available with superior accuracy.

It is a step back presented as a new development in healthcare.

Not necessarily: its low-tech, low-cost nature make it very useful for some applications. Still, as an in-vitro diagnostic device, it is subject to regulatory approval, end of story. Otherwise, it's supposed to be sold as an RUO device ("for research use only")

 

[macaddict06]

Many people in this thread do not have a clue what they are complaining about.

Nailed it.

I will GUARANTEE the number of people ITT complaining about how much the FDA sucks have NEVER done any real drug research in their lives (snake oil doesn't count). It's not entirely their fault; science hasn't always done a good job of communicating what we do to the public, but at the same time, I don't think anyone has any idea how different things would be without the FDA.

The FDA doesn't exist to rain on your little iOS parade. It exists to regulate matters of health and you'd be positively screwed without them regulating that arena.

 

[576316]

Deleted

 

[Roller]

I'm personally not much of a fan of the FDA. I think it's an organization with, perhaps, initially good intentions, but one which has turned into just another political machine. Some of the foods and drugs getting FDA approval are a joke, and many potentially life-saving drugs never get to be used thanks to their slow approval process, or refusal to accept something as legitimate.

How many people have died taking drugs that initially had FDA approval after "extensive testing"? Quite a few!

Personally, I don't think the real qualifier should be "medically diagnostic", unless we want to define that term to mean "used in a medical setting". If this device was going to be approved for use an actual doctor's office or hospital -- fine. Demand it meets certain standards for accuracy.

But anyone buying this off the shelf and using it at home? It might be a diagnostic tool -- but so is researching one's symptoms on the Internet. Just require a warning label on the box telling people to see a professional if they have real medical concerns stemming from the results the device gave, and leave it at that.

Do you have any experience with testing medical devices and medications prior to FDA approval? I do, and I'll be the first to admit that the process is far from perfect. However, even an imperfect process is better than none at all. In this case, the device is clearly intended to perform the same function as some hospital- or office-based diagnostic equipment, and should be subject to some scrutiny.

I'm all for development of smartphone apps and related devices, which have the potential to reduce costs and give people more direct control over their healthcare, but only as long as there is appropriate oversight.

 

[Drunken Master]

Cue class action from consumer group that have number 1'd all over their phone.

I know I'm pissing all over my phone on the reg.

 

[dokindo]

these are the rules, if you want to innovate in this sector you have to lobby a few millions. no exceptions accepted guys.. you should know this by now

This!

Ex-FDA consultants are circling for money.

 

[peterdevries]

these are the rules, if you want to innovate in this sector you have to lobby a few millions. no exceptions accepted guys.. you should know this by now

This!

Ex-FDA consultants are circling for money.

And again nonsense. The application for a 510(k) approval for a medical device such as this is only a few thousand dollars.

Clinical testing is also a few thousand dollars. We did a clinical test on a 160 patients that cost us 30,000 dollars.

Sure, researching, developing, testing and approval on the whole is expensive, but this is an industry where lives are at stake. Do you want to be hooked up to the hart-lung machine that your neighbor built in his garage and that wasn't approved by the FDA? Didn't think so..

Again, 99% of people in this thread have no clue what this all is about..

 

[PracticalMac]

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.

Sorry to say, but I call BC.

I work I the optical sorter industry, and every machine has to be calibrated to a color standard before it can do anything. Without it, it cannot distinguish dark orange from light red.

Those tests have very subtle colors, so it is critical the camera is calibrated and equipment used properly.
The above product seems to have all it needs, just make sure operator does it right.

That said, it should not take FDA more then a month to test.

 

[PracticalMac]

It's not clear from the article, is this company just producing the iOS apps, or also the strips? If it's the strips then I can understand the FDA's concern, but if it's just the app, then how can the FDA say it needs to approve it as the alternative method that most of these strip home-tests rely on is the consumer's eye to compare colours with a chart. Now I'm pretty sure the FDA don't approve consumer's eyeballs, so why should they have to approve an alternative which is potentially going to be more accurate anyway? iOS>eyeOS in this case.

Cameras don't have the same spectrum response as eyes do.
Cameras need color calibration.

The test strip is put in a holder that has precisely colored dots for comparison, and in a light box for perfect light conditions.

The design looks sound, the strips are already vetted, it should be all go.

As long as the operator verifies the results visually and uses it correctly, it will be OK.

 

[rodriguise]

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.

The FDA sucks and is nothing but a tax sink these days. The time and cost that is takes to bring viable medical technology to the table in this country is stifling innovation and literally killing people everyday. In this case the FDA is just pissed they didn't get their cut. We need massive reforms. Furthermore I've been in ERs of some the most supposed best hospitals in the country and found that physicians, especially the one new school ones (under 55) are tending to make just as un-vetted of decisions and often telling people to ignore symptoms or their own bodies. Hell, I've had friends who were denied labs and sent home only to have to return with complete kidney failure. Tests like this could of least given them something on top of the screaming in pain when they came in. Not that there shouldn't be regulations, but we need to be logical about this, the FDA tends to place the needs to the one before the needs the many, and the one is the all holy dolla bill.

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Sorry to say, but I call BC.

I work I the optical sorter industry, and every machine has to be calibrated to a color standard before it can do anything. Without it, it cannot distinguish dark orange from light red.

Those tests have very subtle colors, so it is critical the camera is calibrated and equipment used properly.
The above product seems to have all it needs, just make sure operator does it right.

That said, it should not take FDA more then a month to test.

I know what its all about, and I've seen plenty of FDA "approved" devices kill people. Furthermore, the FDA is typically exempt from liability in these situations. It's gov't body that has gotten way to bloated liked the IRS, the FCC, the USPS, and the UPTO, just to name a few. Yet we blindly place our decisions and sometimes lives in their hands, despite the fact that they've come to exists solely for the purpose to ensure they continue to exist. Its not the developer here that needs the scrutiny its the FDA.

 

[LordJohnWhorfin]

The FDA sucks and is nothing but a tax sink these days. The time and cost that is takes to bring viable medical technology to the table in this country is stifling innovation and literally killing people everyday.
[...]
I know what its all about, and I've seen plenty of FDA "approved" devices kill people. [...]

You're a typical know-nothing who still has to have an opinion about everything. Every single statement of yours is a patented unsubstantiated falsehood taken right out of a Rush Limbaugh, Glen Beck or Wing Nut Daily rant.
Reality is all the agencies you mention work quite well, and they're absolutely necessary. I'm not going to bother giving you the reasons why, first because they've already been abundantly spelled out in this thread, second because people like you are not open to debate, they just want to spew their uninformed, bigoted, insane brainwashed teabagger ultra-libertarian talking points. Go back to your cave. And please don't drive on the roads my tax dollars are paying for.

 

[macaddict06]

Let's stay on topic.

This whole thread has been completely hijacked by this rampant thought that "the government is bad and therefore the FDA is bad and therefore this whole thing about regulating a urinalysis monitor system is completely stupid". Unfortunately, none of the people touting this ideology took the time to do any reading, so I'll pull the salient points for you, in the interest of staying germane to the OP.

"[The FDA is] asking why its medical app hasn't been cleared by the agency."

From uChek's OWN SITE:
"*The uChek urine analyzer is registered with the U.S. FDA as a Class I medical device, product classification "Automated Urinalysis System", Product Code KQO, regulation 862.2900."
Summary: this is a medical device.

From the Bloomberg article:
"The FDA letter points to data submitted for a urine analyzer made by Acon Laboratories Inc. as an example of the information sought from Biosense. Acon, based in San Diego, submitted a 510(k) application, which is the least stringent of FDA device approval pathways that doesn’t typically warrant clinical trials and only requires a company prove their product is similar to one on the market."
Summary: there is a precedent for submitting applications for apps.

Bottom Line: the FDA only approved the physical system, it did not approve the app. The FDA is asking them why they did not seek approval.

 

[peterdevries]

Bottom Line: the FDA only approved the physical system, it did not approve the app. The FDA is asking them why they did not seek approval.

Absolutely agree, thank you. One little correction though: the FDA does not need to approve only the app. It needs to approve the combination of the app
AND the test-strips.

 

[jslewis]

FDA wants it all

Undoubtedly, protecting patients is fundamental. Remember, however, the FDA brought us Thalidamide (and its birth defects), Celebrex (and its associated deaths), Ladar6000 (blinding LASIK device), and more. All of these completed rigorous testing and the expensive FDA approval process. As a physician and a geek I have been in FDA clinical trials. They are rigorous but rarely "smart". They ignore legitimate clinical studies performed outside the US as unworthy. Only the FDA can determine the validity of a process, software, hardware, etc.

Please don't forget that doctors do not stupidly follow test results, they should integrate data from physical exam, history, observation, and various testing modalities. If your doctor doesn't, get a new one.

Infantilizing your doctor is really what the FDA does. Did you know that paid consultants for a company making a new device or drug can sit on the FDA panel with utter disregard for conflict of interests.

If you think the FDA is enlightened, omniscient, and fair consider this story. Allergan, the company making Botox was fined $600 million dollars when it became clear that they promoted the use of the drug for migraines. (It had only been FDA approved for facial cosmetics). A few weeks later, after the money was collected, the FDA approved the use and advertisement of Botox for migraines. If that sounds right to you, there is some Kool-Aide in my fridge.

jslewis

 

[nia820]

I'm finally going to see the day where I can pee on my $700 unlocked iphone instead of those old fashioned pregnancy test sticks to see if I'm preggers or not.

Can't wait.

 

[7enderbender]

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.

Well, as a healthcare professional I'd rather see the FDA dismantled. The federal government should not be in the healthcare business at all.

 

[jonnysods]

Cue class action from consumer group that have number 1'd all over their phone.

That's exactly what I thought as soon as I read this. Smelly water damage.

 

[rodriguise]

You're a typical know-nothing who still has to have an opinion about everything. Every single statement of yours is a patented unsubstantiated falsehood taken right out of a Rush Limbaugh, Glen Beck or Wing Nut Daily rant.
Reality is all the agencies you mention work quite well, and they're absolutely necessary. I'm not going to bother giving you the reasons why, first because they've already been abundantly spelled out in this thread, second because people like you are not open to debate, they just want to spew their uninformed, bigoted, insane brainwashed teabagger ultra-libertarian talking points. Go back to your cave. And please don't drive on the roads my tax dollars are paying for.

As a disabled person, a cancer patient, and father of a deaf child my experience with the FDA is direct and close to heart. The fact that you felt the need to make your attack personal shows a level of immaturity that I find reprehensible and quite common amongst liberals and those that accept everything the government does carte blanche. You really added nothing to the discussion except animosity, bitterness, and hatred. Ironically, yet perhaps not, all the things you accused me of. I suggest in the future, instead of attacking and being basically a ******, you try asking questions or attempt to understand someone else's point of view. Until you can do that then it is you that lacks critical thinking ability, character, or credibility.

 

[HardRain]

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.

But...the FDA does this already everyday, putting people in hospital or dead is what they do best. These guys simply haven't paid their way

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As a disabled person, a cancer patient, and father of a deaf child my experience with the FDA is direct and close to heart. The fact that you felt the need to make your attack personal shows a level of immaturity that I find reprehensible and quite common amongst liberals and those that accept everything the government does carte blanche. You really added nothing to the discussion except animosity, bitterness, and hatred. Ironically, yet perhaps not, all the things you accused me of. I suggest in the future, instead of attacking and being basically a ******, you try asking questions or attempt to understand someone else's point of view. Until you can do that then it is you that lacks critical thinking ability, character, or credibility.

Don't worry mate, there are a few ******, disturbed people here. They have very little life experience, just want to act all superior as some type of pseudo intellectual. Their level of angst and lack of reasoning is a clear sign to simply ignore them.

 

[rodriguise]

Nailed it.

I will GUARANTEE the number of people ITT complaining about how much the FDA sucks have NEVER done any real drug research in their lives (snake oil doesn't count). It's not entirely their fault; science hasn't always done a good job of communicating what we do to the public, but at the same time, I don't think anyone has any idea how different things would be without the FDA.

The FDA doesn't exist to rain on your little iOS parade. It exists to regulate matters of health and you'd be positively screwed without them regulating that arena.

The purpose for the FDA and how it actually functions are entirely different. I have an electronic prosthetic that the manufacturer has a new software for, its being sitting the FDA queue for 2 years. I could drive to Canada and have it installed, but then my US doctors could be fined for supporting it. The manufacturer has paid their dues and did all the studies, research and received full EU approval in 2010 for the upgrade. The U.S. however ignores and outside peer-reviewed research and requires the taxes, fees, and studies to be done here. They keep stalling and charging. They give preferential treatment to U.S. based manufacturers at the expense of patients and don't give a damn if we complain.

Furthermore 100s of thousands of people are affected, or killed, or have to undergo additional surgeries every year because of the failure of FDA "approved" devices. Failures that should have been caught beforehand but were overlooked because the $$$ involved, kickbacks, whatever. They have people on their boards who have direct monetary interests in the medical device companies and they ignore that conflict.

 

[theanimaster]

Hmmm... FDA.... does the word RANBAXY ring a bell?

And just how many people on these boards are taking generic medication from Ranbaxy... you had better do a Google search. Oh wait, here it is:

http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/


It's a long read, but well worth your time and health.

That's the same FDA we're talking about.

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The purpose for the FDA and how it actually functions are entirely different. I have an electronic prosthetic that the manufacturer has a new software for, its being sitting the FDA queue for 2 years. I could drive to Canada and have it installed, but then my US doctors could be fined for supporting it. The manufacturer has paid their dues and did all the studies, research and received full EU approval in 2010 for the upgrade. The U.S. however ignores and outside peer-reviewed research and requires the taxes, fees, and studies to be done here. They keep stalling and charging. The give preferential treatment to U.S. based manufacturers at the expense of patients and don't give a damn if we complain.

Furthermore 100s of thousands of people are affected, or killed, or have to undergo additional surgeries every year because of the failure of FDA "approved" devices. Failures that should have been caught beforehand but were overlooked because the $$$ involved, kickbacks, whatever. They have people on their boards who have direct monetary interests in the medical device companies and they ignore that conflict.

Meanwhile they're expediting the approval of dangerous, tainted drugs as well (see my link on Ranbaxy).

 

[HardRain]

@rodriguise, you make a number of excellent points and clearly have a wealth of personal experience dealing with the FDA. Anyone who attacks you clearly doesn't believe in free speech and would be better off moving to another country.

In terms of the FDA, they were bought out a long time ago (plenty of info online). The highest bidders own the US Government, simple as that, follow the money, it's very easy to see.

Maybe this thread has moved off topic to a degree, or perhaps it has actually moved to the true source of this topic, that of corrupt control over anyone who has innovation.

For example, cures for Cancer were discovered years ago. Powerful drug companies with the support of the FDA have made sure those cures stay hidden from the general public. Too much money is at stake. This is not conspiracy, it is clear and simple fact.

Just do some of your own research folks and don't listen to raving lunatics, spewing personal attacks at anyone simply sharing their own opinion. The level of vitriol should be a clear indicator as to their true nature.