"All I know Shasta submitted their 510K for Genstrip in December,2010. It was predicated on the 2134 One Touch Ultra system(2001) and was approved in 2012. "
You just don't know what you are talking about. And I am not going to discuss this with you any further after tonight. You do yoursewlf and readers a disservice by posting technical nonsense. You obviously do not know how the 510k process works. A predicate device is an earlier FDA approved device that does many of the same things as the new device. The technologies can be totally different. For example Unistrip choose a predicate that is from one of the last versions of OneTouch Basic, a 1970s technology. The OneTouch Basic system was photochemical. The only thing the O/T Basic did that the Unistrip did was report a glucose result. It was certainly not predicated (a verb) on the O/T Basic. Unistrip is an electrochemical device like O/T Ultra, like GenStrip and GenUltimate. The difference between Unistrip and Genstrip is that Unistrip is an exact copy of O/T Ultra, all the way down to the flaws in O/T Ultra, particularly the inability of dealing with high and low hematocrit. Lack of hematocrit correction is one of two factors that leads to spurious high glucose results from Unistrip which can kill diabetics. Genstrip is totally different technology. Put in a way you can understand, Unistrip is a copy of the 2001 O/T Ultra, flaws and all and it shows it. Genstrip is a 2010 improvement that deals with hematocrit issues. GenUltimate a 2015 improved version is even better. None of them are great. In the end the O/T Ultra meter needs a lot of help, but J&J cannot provide this help because they cannot file a new 510K. Their chemistry technology is back in the stone age. But back to the point, a predicate device is not a predicated device. A total misunderstanding and all you end up doing is upsetting a lot of DECN longs that actually pay attention and know of the disinformation peddled.
"All I know Shasta submitted their 510K for Genstrip in December,2010. It was predicated on the 2134 One Touch Ultra system(2001) and was approved in 2012."
Here you go again. You don't know but you are so definitive that nobody else can make an intelligent determination.
""Genstrip is a product conceived and designed by Shasta Technologies LLC, fits into a diagnostic product niche and sell into an estimated 2011 world-wide market of $24 billion. The company has been involved with Genstrip since early 2010.""
Yes KB was accurate and thew response to this quote is twisted. Nobody is claiming otherwise. It was Shasta's concept. They could not make the concept and make it work and it had to be changed by real professionals. Shasta is just the smell on the bottom of your shoe when you step in some. No matter how much you clean it, that shoe will always carry THAT smell.
"The Shasta IP apparently goes back to Selfcare origins(K002134),and incorporates the borrowed..."
No, no no. Take some time and learn the process and learn the technologies. A good place to start is the FDA produced 510K Decision Summary for each of the three products. If you do not grasp the technical issues, I will explain them to you.
May I ask a question? Why do you so dislike Mr. Berman? You get his services for free and he knows what he is doing, yet you are sorry you ever heard of him.
Finally, MediSense is owned by Abbott, not Roche. Sloppy, sloppy.
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