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