What about diagnostic antibodies made non-commercially. Do we need a
disclaimer for those?


Tim Morken, B.S., EMT(MSA), HTL(ASCP)
Infectious Disease Pathology
Centers for Disease Control
MS-G32
1600 Clifton Rd.
Atlanta, GA 30333
USA

email: tim9@cdc.gov
       timcdc@hotmail.com

FAX:  (404)639-3043

----Original Message Follows----
Date: Thu, 03 Dec 1998 09:29:50 -0500
From: beverly.miller@shandon.com
Subject: RE: IHC Disclaimer
To: Robert.Lott@bhsala.com, histonet@pathology.swmed.edu

Let me add some slight clarification to Robert's explanation=2E IHC
primary=20=
antibodies generally fall into class I, with a few in class II=2E The
class=20=
I antibodies are exempt from having to go through the FDA submission=20=
process before marketing, but the class II ones are not exempt=2E As
this=20=
submission process costs the manufacturer a significant amount of
money,=20=
you may find that some of the class II antibodies (ER,PR, Ki-67 and
the=20=
like) are sold not as IHCs, but as ASRs, as the ASRs are exempt from=20=
submission=2E It is conceivable that a company could also market class
I=20=
antibodies as ASRs, but as there is really no advantage to the company
in=20=
doing this, I doubt that you'll see this=2E The bottom line, as
Robert=20=
said, is that the labeling the company puts on the product governs=20=
whether you need the ASR disclaimer or not=2E As an aside, detection=20=
reagents that do not include a primary antibody fall into the
general=20=
purpose reagent category and will be labeled For Laboratory Use=2E They
can=20=
be incorporated into an IHC assay without any restrictions=2E

Bev Miller
Shandon Lipshaw

 -----Original Message-----
From: Robert=2ELott@bhsala=2Ecom [SMTP:PC :Robert=2ELott@bhsala=2Ecom]
Sent: Wednesday, December 02, 1998 8:03 PM
To: histonet@pathology=2Eswmed=2Eedu
Subject: Re: IHC Disclaimer

 << File: ENVELOPE=2ETXT >>

--------------------------------------------------------------------------=20=
 --


Sandy,
Better yet=2E=2E=2E better than trying to decipher the Federal Register,
read
the
article in the November CAP Today, Vol=2E12, No=2E 11 concerning the
disclaimer=2E


The bottom line is that the disclaimer is NOT required on IHC assay
results=2E
The FDA defines IHC reagents as "in vitro diagnostic devices=2E=2E=2E
intended
to
identify, by immunological techniques, antigens in tissue or cytologic
specimens=2E"


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=2E This is essence takes them
out
of
the ASR category=2E


Unlike ASRs (analyte specific reagents; or componenents of "home-brew
tests"),
IHC reagents are labeled with directions for use and performance
claims=2E
Manufacturers cannot make performance claims about ASRs=2E


Therefore, laboratories are NOT required to to use a disclaimer
statement=20=


on
IHC reports as long as the components of your IHC assay are not labeled
"ASRs"
by the manufacturer=2E  As long as you buy the components of your
IHC=20=
assays
from a manufacturer that has been through the FDA labeling and=20=
performance
approval process you're OK=2E This goes for primary antibodies and=20=
detection
systems=2E


Robert Lott, HTL(ASCP)
Baptist Health System
Birmingham, AL
 ------------------( Forwarded letter 1 follows )--------------------
Date: Tue Dec 01 20:00:34 1998
From: ptakes@stereotaxis=2Ewustl=2Eedu
Sender: HistoNet@Pathology=2Eswmed=2Eedu
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=2E
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=2E
See
Clinical Laboratory News 24(4):10, April, 1998=2E


Peter


 --
Peter A=2E Takes, Ph=2ED=2E, RAC
Director, Clinical & Regulatory Affairs
STEREOTAXIS, Inc=2E
Ph=2E 1-314-615-6964; Pager: 841-9351
ptakes@stereotaxis=2Ewustl=2Eedu




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=2E
> I have a copy of the Federal Register relating to the ruling on
> Immunohistochemistry reagents=2E
> 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=2E
> Thanks
> University of Texas Medical Branch at Galveston
> Sandy Hinton

















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