ASR disclaimer and RUO's, was...RE: [Histonet] FITC C4d

Morken, Tim tim.morken <@t>
Wed Dec 6 10:38:40 CST 2006

Yes, the disclaimer is only for ASR's. There is no disclaimer for RUO
antibodies because RUO's are not to be used for diagnostics, at least
they are not to be reported or charged. This is an FDA rule and they say
the CAP is wrong to say a diagnostic lab can use RUO's (CAP has a
section in the checklist that says an RUO can be used if the lab cannot
find the antibody as an ASR or IVD. FDA says this is not correct and no
use of RUO for diagnostics is legal). However, FDA has made no effort to
enforce this rule. Below is my quesiton to FDA and their answer.

Tim Morken
Product Development
Lab Vision - Neomarkers
ThermoFisher Scientific

Here is my question to FDA and their answer. I asked in 2004 and
confirmed this in 2006. 

Recently (Dec 2004,
tp.html) The College of American Pathologists (CAP), the accrediting
agency for diagnostic Anatomic Pathology labs, determined that RUO
antibody reagents are suitable for diagnostic work as long as the
laboratory using them makes a "reasonable" effort to find such
antibodies in IVD or ASR format, and undergoes validation of such

from: Anatomic Pathology checklist, Sept 2004, 
Item # ANP.12425             
"Antibodies, nucleic acid sequences, etc., labeled "Research Use Only"
(RUO) purchased from commercial sources may be used in home brew tests
only if the laboratory has made a reasonable effort to search for IVD or
ASR class reagents.  The results of that failed search should be
documented by the laboratory director."

My questions are:
1)Does the FDA approve of this reversal of the policy to not allow RUO's
for diagnostic use.

2) Is the requirement to be FDA registered now moot for antibody use
(RUO-only  vendors are not usually FDA registered)

3) If RUO's can be used, is there a disclaimer (as for ASR's) that must
be used along with RUO reagents?

-----Original Message-----
From: Gutman, Steve [mailto:SIG <@t> CDRH.FDA.GOV] 
Sent: Tuesday, April 05, 2005 8:14 AM
To: 'tpmorken <@t>'
Cc: St. Pierre, Don J.; Rodgers, Anthony (CDRH); Cardamone, Thomas E.;
Yost, Judith A (CMS)
Subject: FW: 03-393 aqr DSMICA Email Form Response

Dear Mr. Morken,

I was not familiar with this CAP change and will share this with CMS the
organization that grants deemed status to CAP.  While I do think this is
a pragmatic approach and probably well intentioned, I also think
unfortunately it is clearly at odds with the law.  Companies or
laboratories that follow this are potentially in jeopardy of compliance

If you have questions or concerns, please feel free to call me at

Steven Gutman, M.D.
Office of In Vitro Diagnostics

-----Original Message-----
From: histonet-bounces <@t>
[mailto:histonet-bounces <@t>] On Behalf Of Richard
Sent: Wednesday, December 06, 2006 6:45 AM
To: Donna Lawson; histonet <@t>; Mark Tarango
Subject: RE: [Histonet] FITC C4d

I thought the disclaimer was for analyte-specific reagents (ASRs) only?


Richard W. Cartun, Ph.D.
Director, Immunopathology & Histology
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 545-1596
(860) 545-0174 Fax

>>> "Tarango, Mark" <mtarango <@t>> 12/05/06 5:55 PM >>>
I've tried and didn't find one.  It's all about the good faith effort,
if you ask me. . .

You have that FDA disclaimer on the reports afterall, right?

Mark Adam Tarango HT(ASCP)

Histology/Immunohistochemistry Supervisor

Nevada Cancer Institute

One Breakthrough Way

Las Vegas, NV  89135

mtarango <@t> 

Direct Line (702) 822-5112

Fax (702) 939-7663


-----Original Message-----
From: histonet-bounces <@t>
[mailto:histonet-bounces <@t>] On Behalf Of Donna
Sent: Tuesday, December 05, 2006 12:03 PM
To: histonet <@t>
Subject: [Histonet] FITC C4d


Is anyone out there using an indirect FITC labeled C4d antibody that is
NOT an RUO? I can only find 2 and they both say for RUO not for Clinical

Any Help will be greatly appreciated,

Donna Lawson H.T. (ASCP) QIHC
Histology Supervisor
University of Kansas Hospital

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