RE: [Histonet] RUO antibodies

From:"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

-----Original Message-----
From: ANN MARUSKA [mailto:amarusk1@FAIRVIEW.ORG] 
Sent: Tuesday, April 06, 2004 12:55 PM
To: histonet@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 Maruska
Fairview-University Medical Center
Mpls. MN  55454

The information transmitted in this e-mail is intended only for the person
or entity to which it is addressed and may contain confidential and/or
privileged material, including "protected health information."  If you are
not the intended recipient, you are hereby notified that any review,
retransmission, dissemination, distribution, or copying of this message is
strictly prohibited.  If you have received this communication in error,
please destroy and delete this message from any computer and contact us
immediately by return e-mail. <<<>>>

Histonet mailing list

<< Previous Message | Next Message >>