Re: IHC Disclaimer and non-commercial Ab's

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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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Now you're in a truly tricky area.  Many factors and other issues to consider,
largely dependent on where the Abs come from and who uses them for what.
>From an
FDA perspective, if the Abs are made by the docs at your institution, and used
internally, then that falls within their practice of medicine exclusion,
and the
extent of responsibility falls to the physicians.  FDA cannot, by rule,
the practice of medicine.  However, there may be HCFA issues involved, and you
must be sure the tests are validated.  No disclaimer from an FDA approach.

If the Abs are non-commercial, but given or sold to you by another institution,
FDA could get into the picture, because now the Abs are changing hands for
clinical use, and this can cause a problem greater than the disclaimer.
the Ab availability is not publicized, a commercial transaction of sorts
has taken
place.  More a problem for the source of the Ab than the end user.  However, if
your institution performs billable tests for outside institutions for
purposes, now FDA can potentially enter the picture.  Although the Abs are not
specifically commercialized, the tests employing them, in principle, are,
and FDA
could possibly get into the picture.  Labeling of the 'products' and subsequent
disclaimers would only be one of the issues in this case.

A regulatory attorney might correct me on some of the finer points here, but my
view of the current rules would be that these should be valid concerns.
Especially in the unlikely event of an aberrant diagnosis.

Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Ph. 1-314-615-6964; Pager: 841-9351

Tim Morken wrote:

> 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
> email:
> FAX:  (404)639-3043
> ----Original Message Follows----
> Date: Thu, 03 Dec 1998 09:29:50 -0500
> From:
> Subject: RE: IHC Disclaimer
> To:,
> 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 >>
> 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
> 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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