Replies to post #32731 on Decision Diagnostics Corp (DECN)

[efgplanner]

Wow. Great response. Love the conviction.

[scottsmith]

I think if you are good at something then you should be paid for it. Which is why I plan to petition anyone who will listen and demand Keith Berman receive a salary.

[scoop9]

My bad on Medisense,I mixed Roche up with Abbott(acquired in 95).

Predicate:found or base something on.

Predicated:Based on.

I know exactly what a predicate device is.

This should satisfy your parsing.

"All I know Shasta submitted their 510K for Genstrip in December,2010. The predicate device on the 510 K is the 2134 One Touch Ultra system(2001),and was approved in 2012. "

O'my...talk about nothing.

"Nobody is claiming otherwise."

You were,you said Shasta didn't have anything to do with the design of genstrip.

Yes,yes,yes, on the borrowed technology,otherwise that common thread would not be as key as it is.


Scoop

[scoop9]

All this technical mumbo jumbo is not the point.

From the FDA..

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"What is Substantial Equivalence

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.

A device is substantially equivalent if, in comparison to a predicate it:

has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable."

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It don't matter how it works,just that it does.

Equivalency is equivalency...

If the "borrowed technology" is key(as in it makes all the difference w/r to performance) to the OneTouch Ultra platform,then it would find itself in these other products also in order to produce equivalency.

I really don't care if the Unistrip 510 predicate was the Original OneTouch strip,or that the Genstrip used the OneTouch Ultra platform. All that matters is that they BOTH passed equivalency.

That both of the devices are at least as safe and effective as the legally marketed device.

"AT LEAST"...is the key.

So you see, even with two different predicates,they both achieved OneTouch Ultra equivalency. What does that tell you?


Scoop