Replies to post #86707 on Decision Diagnostics Corp (DECN)

[IPwatcher]

Can you help me find something, or maybe IP can. Bozo Berman stated he had perfected the technology for glucose monitoring. I don't see Berman selling any meters that FDA cleared for impedance technology.

Can you help me find where Berman is selling this perfected technology or where it has even been cleared by the FDA for sale yet?

Its easy enough to find this stuff out.
Look at the FDA searchable 510K webite under product code NBW.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

This is the FDA product code for OTC blood glucose measurement systems.
You can also check LFR which is Glucose dehydrogenase based test strips as well as CGA which are glucose oxidase based test strips.
These will show the 510K summaries for all APPROVED products.

The genstrip (shasta) shows up in CGA from 2012 as K103542. I believe this has been rebranded as This is what DECN inherited from shasta and it looks like this may be all they are allowed to sell in the US on that basis. This covers strips made to work with Lifescan One Touch ultra meters only (presumably this is what DECN remranded GenUltimate!?) . No other 510K that could relate to DECN products that I can find, but please as I always say - don't take my word for it. Go look for yourself. I may have missed something. (You can download into excel and use filters and searches to make looking easier)
I can find no approval for either DECN, Pharmatech, nor The Bio co.
So it looks like none of DECN's own meters (or their new test strip technologies) - GenPrecis or whatever - have been granted FDA approval as yet, unless I am missing something or they are relying on a 510K from somewhere else (i.e. somebody else's strip).
On this basis, I would assume that they have not yet been sold into the US market for human use!
And a quick look at the Full Circle diabetes website suggests that all DECN currently have for sale for human use is Genultimate for use with legacy ultra meters.

It does rather beg the question of how much experience of dealing with the FDA Berman et al at DECN can legitimately lay claim to?

w.r.t. smbg which would seem to be their core (only?) product, DECN are thus far relying on a singlle FDA 510K product that was developed, submitted through 510K and then granted to somebody else, and which they subsequently acquired all rights to.
There is no evidence that I can see of DECN successfully negotiating a single one of their own products through an FDA submission?

Which gets me thinking: What claim was it Pluto made about the number of times a DECN FDA approval was bounced by the FDA? Which one was it?

I need to go look at this! Will report back.