[Histonet] FW: ASRs

Wed Jan 28 12:15:53 CST 2004

I found another link which has the FDA Draft Compliance Policy Guide.
http://www.fda.gov/cdrh/comp/ivddrfg.html

Important quote:

"Devices labeled "For Research Use" are mislabeled if the device is
being used for investigational purposes, i.e., in a clinical study, even
if involving only one subject, where the diagnostic or prognostic
measurement will be reported to the patient's physician or medical
records or will be used to assess the patient's condition, regardless of
whether or not confirmatory tests or procedures are used. Research use
is limited to the initial research phase of product development that is
necessary to identify test kit methods, components, and analytes to be
measured or to laboratory research that is entirely unrelated to product
development. See 21 CFR 809.10(c)(2)(I).

However, the Agency recognizes that certain improperly commercialized
IVD's have been in extensive clinical use for a significant period of
time. The Agency further recognizes that immediate regulatory action
against certain of these IVD's might result in adverse consequences to
individual patients and the public health. Therefore, FDA is publishing
this CPG in order to describe the Agency's enforcement policy, which
includes the Agency's intention to exercise discretion for designated
periods of time, so as not to cause undue disruption to the possibly
beneficial use of IVD's that have not received Agency clearance prior to
commercialization."

This is from 1998 and is a draft to get public comments prior to issuing
a final Compliance Policy Guide.  I can't find where a final CPG was
ever released. 

Ross M Stapf
Histopathology Manager
Baylor University Medical Center
3500 Gaston Ave.
Dallas, TX 75246
214-820-2465
214-820-4110 fax
RossS <@t> baylorhealth.edu

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Stapf,
Ross
Sent: Wednesday, January 28, 2004 11:55 AM
To: Horn, Hazel V; Mitchell, Jeannette M.; Histonet <@t> pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs

I have found a few links regarding ASR's, RUO's and what has happened in
the USA with these rules.

http://www.ashi-hla.org/usefullinksfiles/asr-freg.pdf
This one is the FDA ruling regarding ASR's.  Especially read Comment 16
on page 8.

http://www.fda.gov/cdrh/comp/fr01598b.html
http://www.gklaw.com/powerpoint/IP/Analyte_Specific_Reagent_Regulations.
ppt

The last one is a PowerPoint presentation prepared by a PhD and an
attorney on the subject.  If you download it and then open it in
PowerPoint viewing the presenter's notes, it has a lot of information.

I admit that I'm still trying to figure it out.  I hope someone here
knows for certain.  As far as I can tell, the FDA does not want
Pathologist's to use RUO's in their diagnosis, but has not begun to
enforce this and may not have published final rules stating this.

Please feel free to read the above links and disagree.  I'm not an
expert.  I'm trying to figure this out myself.

Ross M Stapf
Histopathology Manager
Baylor University Medical Center
3500 Gaston Ave.
Dallas, TX 75246
214-820-2465

214-820-4110 fax
RossS <@t> baylorhealth.edu

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Pat
Zeitlow
Sent: Wednesday, January 28, 2004 9:30 AM
To: Horn, Hazel V; Mitchell, Jeannette M.; Histonet <@t> pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs

This discussion takes place frequently and I also would like final
resolution.  The following statement is from CAP Advocacy (11/98) and
seems clear enough.  Please let me know if something more current
exists.

ASR FACT SHEET
"The FDA very clearly distinguishes ASRs from Immunohistochemistry (IHC)
reagents (final rule effective Aug. 17, 1998).  The FDA defines IHCs as
"in vitro diagnostic devices...intended to identify, by immunological
techniques, antigens in tissue or cytologic specimens."  Unlike ASRs,
IHCs are labeled by manufacturers with directions for use and
performance indications."

Based upon that, my interpretation and practice has been that
disclaimers are unnecessary on IHC antibodies in general.  It may be
that you could be using antibodies that are worked up with home brew
methods (do not come with instructions and performance indications) in
which case I would assume the disclaimer would be appropriate.

I look forward to the responses from the group on this.
Pat Zeitlow
Boyce & Bynum Laboratories
-----Original Message-----
From: Horn, Hazel V [mailto:HornHV <@t> archildrens.org]

Sent: Tuesday, January 27, 2004 1:43 PM
To: 'Mitchell, Jeannette M.'; Histonet <@t> pathology.swmed.edu
Subject: RE: [Histonet] FW: ASRs

The disclaimer is necessary if the antibody is labeled ASR by the
manufacturer.   If it is, you must use the disclaimer.    Almost all of
our
antibodies are IVD or ASR and we bill for those.  But, if we have a RUO
antibody (we have 2)  we  do not bill for those immunos.   It's not a
CAP
requirement,  it's a CLIA requirement for the statement and CAP is just
following through with their inspections to see if labs are complying.

Hazel Horn, HT/HTL (ASCP)
Histology Supervisor
Arkansas Children's Hospital

Phone - 501.364.4240
Fax - 501.364.3912

-----Original Message-----
From: Mitchell, Jeannette M. [mailto:Jeannette.Mitchell <@t> vtmednet.org]

Sent: Tuesday, January 27, 2004 1:05 PM
To: Histonet <@t> pathology.swmed.edu
Subject: [Histonet] FW: ASRs

> Can folks tell me what they are doing with regard to CAP Checklist
> Dec. 2003 question  # ANP.12425 regarding ASRs (Analyte Specific

> Reagents) ? We currently do not have any disclaimer in our patient

> surgical reports because all our antibodies are commercially produced

> (not "home brews"). In reading this recently revised requirement

> however it sounds like we need to have this statement in all our

> reports that have had IHC performed. Most of the antibodies we use

> have package inserts saying for "Research Use Only".
>

> I'd appreciate any feedback as to whether the CAP recommended
> disclaimer is necessary with commercially bought antibodies (not in

> kits). thanks Jude
> Jude Carpenter, BS, HTL(ASCP)
> Chief Technologist for Autopsy/Histology/Surgical Pathology 111
> Colchester Ave. Burlington,  VT  05401
> jude.carpenter <@t> vtmednet.org
> (802)847-5116
> fax: (802)847-3509
>

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