Denise ,
This means that the good people at Ventana are waiting for a phone call from
the FDA saying their Her-2 is now approved.  They have had their antibody
awaiting approval for some time and we all how quickly the feds move on
these things....
Wanda Shotsberger Gray HT (ASCP)
Charleston SC
jfwan@infoave.net

 -----Original Message-----
From: 	Wilson Denise [mailto:DWilson@brookdale.edu]
Sent:	Tuesday, September 19, 2000 1:46 PM
To:	'histonetpathologyswmededu'
Subject:	FW: ventana nexes - her2neu

I am more confused than ever by this answer!



> I am writing to clear up some confusion that exists regarding the
> regulatory
> status of one of our products, Ventana c-erbB-2 Primary Antibody, Clone
> CB11.  Currently this product is marketed as an Analyte Specific Reagent.
> It is, however, submitted to the FDA for review to obtain IVD labeling.
>
> The type of submission filed with the FDA was a Premarket Approval, or
> PMA.
> This is due to the fact that the FDA has classified this product as a
> Class
> III Device.  Under 21CFR 864.1860 we are required by law to submit a PMA
> and
> have it approved prior to marketing this product as an IVD test.  The FDA
> will not accept a 510(k) submission for immunohistochemical assays for
> Her-2/neu.  Neither Ventana nor any other company may submit a 510(k).
>
> Hope this clears up any misinformation.
> Regards!
>
> BJ Kerns
> Director of Worldwide Strategic Marketing
> Advanced Staining Reagents
> 3865 N Business Center Drive
> Tucson, AZ 85705
> 1-800-227-2155 ext. 3577
>
> -----Original Message-----
> From: Wilson, Denise [mailto:DWilson@brookdale.edu]
> Sent: Tuesday, September 19, 2000 9:33 AM
> To: 'histonet@pathology.swmed.edu'
> Subject: ventana nexes - her2neu
>
>
>
> >  I am considering getting the Ventana Nexes for immuno but recently came
> > accross some disturbing information. I was told that the her2Neu from
> > ventana was not FDA approved, and that a doctor cannot prescribe
> treatment
> > based on this result. Does anyone out there know anything about this?
> > Please enlighten me on this subject, and while you are at it, pros and
> > cons of the nexes and Dako machines.
> > > Thanks
> > > Denise Wilson
> > > Brookdale Hospital
> > >
> >
>