Let me add some slight clarification to Robert's explanation. IHC primary
antibodies generally fall into class I, with a few in class II. The class I
antibodies are exempt from having to go through the FDA submission process
before marketing, but the class II ones are not exempt. As this submission
process costs the manufacturer a significant amount of money, you may find
that some of the class II antibodies (ER,PR, Ki-67 and the like) are sold
not as IHCs, but as ASRs, as the ASRs are exempt from submission. It is
conceivable that a company could also market class I antibodies as ASRs,
but as there is really no advantage to the company in doing this, I doubt
that you'll see this. The bottom line, as Robert said, is that the labeling
the company puts on the product governs whether you need the ASR disclaimer
or not. As an aside, detection reagents that do not include a primary
antibody fall into the general purpose reagent category and will be labeled
For Laboratory Use. They can be incorporated into an IHC assay without any
restrictions.

Bev Miller
Shandon Lipshaw

 -----Original Message-----
From: Robert.Lott@bhsala.com [SMTP:PC :Robert.Lott@bhsala.com]
Sent: Wednesday, December 02, 1998 8:03 PM
To: histonet@pathology.swmed.edu
Subject: Re: IHC Disclaimer

 << File: ENVELOPE.TXT >>
 --------------------------------------------------------------------------  --


Sandy,
Better yet... better than trying to decipher the Federal Register, read
the
article in the November CAP Today, Vol.12, No. 11 concerning the
disclaimer.


The bottom line is that the disclaimer is NOT required on IHC assay
results.
The FDA defines IHC reagents as "in vitro diagnostic devices... intended
to
identify, by immunological techniques, antigens in tissue or cytologic
specimens."


The new FDA requirements (which went into effect Aug 17th) for use of
IHC reagents, required that manufacturers of IHC reagents discontinue
using
the research or investigational purposes labeling and instead adhere to
"new labeling and approval" requirements. This is essence takes them out
of
the ASR category.


Unlike ASRs (analyte specific reagents; or componenents of "home-brew
tests"),
IHC reagents are labeled with directions for use and performance claims.
Manufacturers cannot make performance claims about ASRs.


Therefore, laboratories are NOT required to to use a disclaimer statement

on
IHC reports as long as the components of your IHC assay are not labeled
"ASRs"
by the manufacturer.  As long as you buy the components of your IHC assays
from a manufacturer that has been through the FDA labeling and performance
approval process you're OK. This goes for primary antibodies and detection
systems.


Robert Lott, HTL(ASCP)
Baptist Health System
Birmingham, AL
 ------------------( Forwarded letter 1 follows )--------------------
Date: Tue Dec 01 20:00:34 1998
From: ptakes@stereotaxis.wustl.edu
Sender: HistoNet@Pathology.swmed.edu
Subject: Re: IHC Disclaimer


Sandy:


The disclaimer in the Federal Register notice will likely be required by
CAP for
tests where an ASR is used, in accordance with FDA requirements.  Please
note
that FDA now requires labs use that disclaimer, and labs employing ASRs
now
fall
within FDA's jurisdiction for compliance with the report label
regulations.
See
Clinical Laboratory News 24(4):10, April, 1998.


Peter


 --
Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
STEREOTAXIS, Inc.
Ph. 1-314-615-6964; Pager: 841-9351
ptakes@stereotaxis.wustl.edu




Hinton, Sandy (by way of Histonet) wrote:


> This may be a subject that has been discussed previously but if so I
was off
> the network at that time.
> I have a copy of the Federal Register relating to the ruling on
> Immunohistochemistry reagents.
> My question is what disclaimer is CAP requiring us to add to final
Surgical
> Pathology reports, to address Immunohistochemistry procedures?
> Please feel free to email or FAX (409) 772-4676, your response.
> Thanks
> University of Texas Medical Branch at Galveston
> Sandy Hinton