According to the information I've received we do need to use the disclaimer
on "home brew" antibodies.
Sandy Hinton

> ----------
> From: 	Tim Morken[SMTP:timcdc@hotmail.com]
> Sent: 	Thursday, December 03, 1998 7:53 PM
> To: 	histonet@pathology.swmed.edu
> Subject: 	IHC Disclaimer and non-commercial Ab's
>
> 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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