iPhone Urinalysis App Draws U.S. Government Scrutiny

[TMar]

how do you know the app's results are real without any testing or verification?

The app stores results, though it's capable of reading it, it's mostly just for storage of information. What's tested and verified are the strips. It's not really intended to be the sole reading device of the strips, your eyes are.

 

[Ralf The Dog]

Easy solution, "For entertainment use only."

Ok, lets go over your results.

Item 1, urinalysis.

I'm a what????

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.

Tell that to the man who is dead, because, the device gave him the wrong glucose numbers.

RE: Self driving car. It's not that big of a deal, when you cellphone crashes. When your car crashes at 80 MPH, that is a bit more serious.

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.

It is a medical device.

 

[duaneu]

I sure hope some other news pops up so we don't have to look at the urinalysis story through the whole holiday weekend.

 

[palmharbor]

[url=http://cdn.macrumors.com/im/macrumorsthreadlogodarkd.png]Image[/url]


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.

Image​

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:
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.

Article Link: iPhone Urinalysis App Draws U.S. Government Scrutiny

_______________________________________
How long before they make a recreational drug test? Soon, I bet...big brother is NOT the govt...its private business.

 

[TimeSquareDesi]

iPeeFreely 1.0 is going to have some trouble making it to market

But, yeah, as others have mentioned - gross.

 

[macaddict06]

Screw the FDA. Here's another government agency that directly results in skyrocketing health care costs and overregulation of helpful devices and ideas such as this one.

Yes, of course. A good example of this over-regulation may be found here:

http://en.wikipedia.org/wiki/New_En...er_meningitis_outbreak#Compounding_pharmacies

TL;DR - if you don't want meningitis, don't go to places that aren't FDA approved (meningitis is quite fatal, especially if introduced DIRECTLY into the central nervous system).

Guys, the FDA is good. The only time you're going to notice how good this "oversight" is is when you don't have it and some pathologist is looking at slides of your brain tissue - but you're going to be dead by then.

 

[toaster64]

Time to resurrect, "There's an app for that!" campaign.

Ctm, that's what I was thinking.

 

[old-wiz]

This is a real pisser of a story!

The things that went through my mind when I read the headline... I kept thinking of the oopsies from people who drop their phones in the toilet.

 

[klover]

Oh piss off.

 

[One Bad Duck]

is it just me?

Is it just me or does NO ONE ELSE notice the grammatical error in the first line of the article. Why would the FDA ask BioSense technologies why their app hasn't been approved? Isn't it the other way around?

I know you Americans slaughter English but this just isn't right...

c'mon macrumors

 

[Quazimojo]

I can imagine all the blank stares when someone pulls out their phone and asks you to urinate on it.

 

[Renzatic]

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

"So, uh...what do I do? Pee into the headphone jack? I guess that makes sense. Let's give this a try..."

 

[demodave]

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.

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:
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.

Article Link: iPhone Urinalysis App Draws U.S. Government Scrutiny

This concern should not surprise anyone. The FDA regularly gets involved in medical/pharmaceutical/dietary issues. One of the (IMNSHO, few) reasons that legitimate pharmaceutical drugs are so expensive is the fact that they cannot be sold until they have undergone an arduous testing and approval process. I can't say that BioSense skipped those procedures, but that seems to be the jist of what the FDA is saying. I can't, by way of example, say what process my blood pressure meter went through for my iPhone. But I do own one.

 

[sbrhwkp3]

Yes, of course. A good example of this over-regulation may be found here:

http://en.wikipedia.org/wiki/New_En...er_meningitis_outbreak#Compounding_pharmacies

TL;DR - if you don't want meningitis, don't go to places that aren't FDA approved (meningitis is quite fatal, especially if introduced DIRECTLY into the central nervous system).

Guys, the FDA is good. The only time you're going to notice how good this "oversight" is is when you don't have it and some pathologist is looking at slides of your brain tissue - but you're going to be dead by then.

Like there wouldn't be oversight without the FDA. It'd be even better. Multiple, private organizations that taxpayers don't have to fund.

Look at how the internet has spurred review sites like Yelp and Zagat.

Without the FDA, breakthrough medications would get to the public much faster and would cost much less.

There is nothing good about the FDA whatsoever.

 

[cclloyd]

I'm not peeing on my phone to check my urine.

 

[miniyou64]

.

 

[peterdevries]

Why should it need FDA approval? That's only really needed if it will be used by medical professionals as part of patient care. It people use it of their own accord as part of routine lab work, this doesn't need FDA approval.

Nonsense, these are point of care diagnostics devices for use by the patient that need FDA approval. They are no toys. The reason for FDA approval is that diabetes 1 patients for instance that use these strips to test their glucose levels, need to determine their insulin requirement. Inaccurate measuring can cause hypoglycemia or hyperglycemia.

The accuracy requirements for point of care diagnostic devices have just been tightened by the ISO in May. These guys will have a hard time getting approval.

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

 

[ConCat]

Tell that to the man who is dead, because, the device gave him the wrong glucose numbers.

RE: Self driving car. It's not that big of a deal, when you cellphone crashes. When your car crashes at 80 MPH, that is a bit more serious.

Once upon a time in the great US of A, people would sue if someone caused this kind of damage due to negligence, and that would be enough of a motivator to not be an idiot when designing such products. Now we just ask the nanny state to take care of everything for us. My how times have changed...

 

[cycomiko]

Like there wouldn't be oversight without the FDA. It'd be even better. Multiple, private organizations that taxpayers don't have to fund.

Look at how the internet has spurred review sites like Yelp and Zagat.

Without the FDA, breakthrough medications would get to the public much faster and would cost much less.

There is nothing good about the FDA whatsoever.

ylp are barely reliable for reviews, but you think it would make a superiior replacment for drug approval process?

Which drugs are you on, adn are thy reviewed on yelp?

----------

Once upon a time in the great US of A, people would sue if someone caused this kind of damage due to negligence, and that would be enough of a motivator to not be an idiot when designing such products. Now we just ask the nanny state to take care of everything for us. My how times have changed...

So, how do you plan on suing once you have died in the crash at 80mph?

 

[peterdevries]

There is nothing good about the FDA whatsoever.

Do you know how many new drugs and devices get rejected by the FDA that would cause incredible damage to people if allowed on the market?

Take this recent example: http://www.guardian.co.uk/society/2006/mar/15/health.medicineandhealth2

do you think the market's self regulating power would kick in fast enough to prevent the hundreds of deaths from a drug like this, as opposed to the tightly regulated process by the FDA and EMA where damage was "limited"?

You truly have no idea what you are talking about.

 

[neuropsychguy]

Nonsense, these are point of care diagnostics devices for use by the patient that need FDA approval. They are no toys. The reason for FDA approval is that diabetes 1 patients for instance that use these strips to test their glucose levels, need to determine their insulin requirement. Inaccurate measuring can cause hypoglycemia or hyperglycemia.

The accuracy requirements for point of care diagnostic devices have just been tightened by the ISO in May. These guys will have a hard time getting approval.

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

I think the FDA is important (I am a health care professional) but my point was that as long as this is used as informational and not medically diagnostic, it does not need FDA approval. The company could seek FDA-approval but that's a tortuous process without guarantee of success. As I wrote in my previous post, a number of clinical tests used for patient care are not FDA-approved. Many used are in the process of approval but with research validation and when used in conjunction with clinical judgment many diagnostic tests can be important even without FDA-approval.

That being said, this tool should not replace standard care without solid peer-reviewed evidence that it is at least as reliable and valid as standard care.

Medication are one thing but this is something else entirely. A diabetic should not using this instead of a finger prick until it's been demonstrated to be as reliable. That being said, a lot of people with diabetes do not check their sugar levels regularly because they do not like the established methods (I see this nearly every week in clinical practice - people hate the blood tests so they rarely do them). If this would allow people to check sugars less invasively then it is potentially a big service. However, I'm not suggesting it replace standard of care (although I'd be surprised if it wasn't as accurate as established methods).

We also have to remember that the FDA only provides oversight to the U.S. Other countries do what they want to do and will do it. This is a world-wide product and if the FDA doesn't approve it, it will only keep it from being used in the U.S. The risk is that the FDA will start to go after Apple or Google for allowing these apps. That would be a real tragedy.

 

[NightFox]

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
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.

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.

 

[peterdevries]

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.

The FDA and EMA also require approval of devices that use test-strips or other technologies manufactured by third parties. An example is Cellnovo's insulin pump / SMBG combination, which is just a clever combination of existing and available technologies. It still needs approval.

The point is that many patients cannot distinguish between "informational" medical devices and true diagnostic devices. In addition, the functionality and accuracy of a product might change, even if it uses established technology. If therefore a manufacturer decides to launch a product that is specifically aimed at providing diagnostic information, whether it is serious, informational or for fun, then it needs approval.

 

[peterdevries]

I think the FDA is important (I am a health care professional) but my point was that as long as this is used as informational and not medically diagnostic, it does not need FDA approval.

How is a less educated patient supposed to distinguish between an informational and a medically diagnostic device? This is product is marketed no different than FDA approved devices.

That being said, this tool should not replace standard care without solid peer-reviewed evidence that it is at least as reliable and valid as standard care.

I agree, but it is competing with the vastly superior in accuracy blood testing methods such as SMBG. It is akin to offering wooden wheels on a car. A step back for the user, and it should not be endorsed.

 

[Roller]

I think the FDA is important (I am a health care professional) but my point was that as long as this is used as informational and not medically diagnostic, it does not need FDA approval.

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.