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
> > > 
> > 
>