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