Re: FDA disclaimer for immunos

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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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Many manufacturers are now or will soon be labeling their antibodies as
'Analyte Specific Reagents', or ASRs.  This new allowance by FDA brings useful
antibodies faster to market, but also invokes some restrictions on the claims
manufacturers can make.  In addition, use of antibodies labeled as ASRs opens
the door for FDA inspection of clinical laboratories (previously not accessible
to FDA for the most part), although this may be unlikely unless there are
obvious abuses.  However, part of the new regulation, which assures HCFA will
look for enforcement to a point, requires that labs using an ASR in an IHC or
other test include on the lab reports the following statement: "This test was
developed and its performance characteristics determined by (Laboratory Name).
It has not been cleared or approved by the U.S. Food and Drug Administration."
[62 Federal Register pg. 62259, 11/21/97; to be codified at 21 CFR 809.30(e)]
This rule takes full effect of law on 11/23/98, i.e., next week.

For antibodies labeled "For In Vitro Diagnostic Use", this disclaimer
requirement and the associated restrictions do not apply.

More information on the ASR rule can be viewed on the JCIM web site
[] or the FDA web site [].

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

Barnhart, Tammy wrote:

> A few  days ago, someone (sorry! to quick with the delete button) mentioned
> a disclaimer required by the FDA on all reports containing
> immunohistochemical results.  This is new news to me and would like anyone
> with info about this to let me know what the requirements are and how they
> are addressing it.  I would appreciate any and all responses.  Thanx in
> advance,
> Tammy Barnhart, HTL (ASCP)
> Anatomic Pathology Supervisor
> Pathology Consultants/St Alexius Medical Center
> Bismarck, ND

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