[Histonet] RUO antibodies

[Morken, Tim - Labvision]

Ann, the FDA invented the ASR designation to get around the RUO dilemmma
(how to justify using a reagent  marked "research use only" for
diagnostics). The FDA doesn't want diagnostic labs using antibodies labeled
as RUO's. The solution is to ask your vendor to supply an ASR datasheet. It
will be the same antibody, just marketed differently, and will satisfy an
FDA inspector. Whatevery you do, it should be worked up as an ASR - ie, you
need to do your own validation studies.

Tim Morken
Lab Vision / Neomarkers
www.labvision.com
 

-----Original Message-----
From: ANN MARUSKA [mailto:amarusk1 <@t> FAIRVIEW.ORG] 
Sent: Tuesday, April 06, 2004 12:55 PM
To: histonet <@t> pathology.swmed.EDU
Subject: [Histonet] RUO antibodies


Hi histonetters,
 
For those who use RUO antibodies in a clinical setting, how do you work up
these products?  Is your documentation any different than when you use ASR
or IVD products? Thanks for your input.
 
Ann
 
Ann Maruska
Fairview-University Medical Center
Mpls. MN  55454
amarusk1 <@t> fairview.org
612-273-9119

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