gosox12
Just for the record I am no expert I am just sharing the information that I have come across take it for what it is worth.
The following is an exerpt from an book (on line) that was given to me by another stock holder. The book is on the priciples of developing drugs,diagnostics, and devices.
<<< 510(k) submission type and content
There is no specific 510(k) form but instead a format for the submission is described
in 21 CFR 807 and in multiple guidance documents by the FDA. The term 510(k)
refers to the original section of the CFR that described the process of clearing a
device that demonstrates substantial equivalence to a device already on the market
before 1976 or another 510(k) cleared device on the market currently (a predicate
device). Since the 510(k) process is much shorter than the PMA route, most
companies try to qualify their devices into the 510(k) pathway. However, as this
process may not generate adequate clinical data to satisfy insurance companies or
other payers, often manufacturers will benefit by performing more extensive clinical
studies to show the specific clinical benefits of the new device or technology (see
Chapter 7 for detailed discussion). To identify a list of 510(k) cleared devices that
might be predicate devices, see Section 5.5.3.>>>
So they did the study using the petri dish as the SE device the FDA Ok'd it. Now they are doing the trials to satisfy the Insurance companies or other players i.e. companies that want to use the products also the FDA wants to make sure that the third party (in this case TMC) did its work properly and if they did not it would show up in the trials.
I am guessing that the hospitals that will be doing these trials will be buying kits during the processso that is a plus and if the outcome is good they will continue to do so. I don't this for sure however.
Andre
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