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.
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iPhone Urinalysis App Draws U.S. Government Scrutiny
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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.
Easy solution, "For entertainment use only." 
Ok, lets go over your results.
Item 1, urinalysis.
I'm a what????
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.
It is a medical device.
Ok, lets go over your results.
Item 1, urinalysis.
I'm a what????
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.
It is a medical device.
I sure hope some other news pops up so we don't have to look at the urinalysis story through the whole holiday weekend.
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How long before they make a recreational drug test? Soon, I bet...big brother is NOT the govt...its private business.
iPeeFreely 1.0 is going to have some trouble making it to market
But, yeah, as others have mentioned - gross.
But, yeah, as others have mentioned - gross.
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.
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.
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.
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
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
I can imagine all the blank stares when someone pulls out their phone and asks you to urinate on it.
"So, uh...what do I do? Pee into the headphone jack? I guess that makes sense. Let's give this a try..."
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.
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.
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.
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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...
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?
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So, how do you plan on suing once you have died in the crash at 80mph?
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.
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.
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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.
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.
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.
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.