[Histonet] ASR disclaimer question

[Pat Zeitlow]

Interestingly, I just got inspected yesterday and had a lengthy
discussion with the inspector on ASR disclaimers.  My strong opinion is
that you do not need to use the disclaimer unless you are using
antibodies or reagents that would be considered "home brew" (i.e.
Detection systems not purchased ready to use, antibodies with no
instructions for use, etc.).    All of the reagents and antibodies that
we use (regardless of manufacturer labeling) come with directions for
use and performance indications, therefore we do not use the disclaimer.
Naturally we validate every antibody and reagent before placing any
protocol in use. There is a lengthy commentary in the newest checklist
that I think clearly supports our decision not to use the disclaimer.
The quote you included says it all.  I produced a copy of the final
rules with that highlighted for the inspector.  I did not get sited nor
was it recommended that I add the disclaimer.  I look forward to the
many opinions I will read on the Histonet.

Pat

-----Original Message-----
From: Histology SLU [mailto:sluhisto <@t> yahoo.com] 
Sent: Tuesday, March 15, 2005 9:14 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] ASR disclaimer question

Hello All:
 
 I have information from the CAP website from 10/2003 that states: 'The
FDA very clearly distinguishes ASR's from immunohistochemistry (IHC)
reagents (final rule effective Aug. 17 1998).  The FDA defines IHC's as
"in vitro diagnostic devices....intended to identify, by immunological
techniques, antigens in tissue or cytologic specimens."  Unlike ASR's,
IHC's are labeled by manufacturers with directions for use and
performance indications.'  I have checked with all of my vendors and all
actually label their antibodies as IVD, research, or ASR.  Those
companies that have ASR antibodies available always use the letters ASR
in the catalog number (at least all of the ones I have contacted).
Using all of this information, our lab does not use ANY ASR's, so in you
all's professional opinion, must we include the disclaimer?
 
For those of you that have been inspected lately, what specifically are
the inspector's comments about this topic?
 
As always, it will be great to hear all of your feedback.  Thanks, in
advance.
 
Susan

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