I will try to address your question, put if I miss the point please let me
know and I will try again.  If the manufacturer classifies the primary
antibody as an ASR (Analyte Specific Reagent), then the laboratory that
purchases the antibody is to put a disclaimer in the final surgical report.


The disclaimer that has to be present is that:

"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."

There may be additional verbage added to the report and CAP recommends one
of two versions.  I can supply you with these if you need.  I also have a
copy of the Final Rule if you would like it.

The whys of the regulation are because the FDA panel that addressed ASR's,
determined that the primary risks to health presented by ASR's sold to
clinical laboratories are that they may be manufactured with variable
quality, or be inappropriately labeled, or be used by persons without
adequate qualifications.  The panel also was concerned that practitioners
ordering the in-house tests made from ASR's may be unaware that the clinical
performance characteristics of these tests have not been independently
reviewed by FDA.  In Addition, the panel identified a subset of ASR's whose
use posed unique risks to public health because of the substantial clinical
impact of the information generated using these devices.

The rule went into effect on November 23, 1998.

I hope this is what you needed.

Debbie J. Siena
NSH Legislative Chairperson
Baylor University Medical Center
Dallas, TX 76246
214-820-2465

-----Original Message-----
From: Dave Tacha [mailto:dave@biocare.net]
Sent: Tuesday, January 25, 2000 5:01 PM
To: histonet@Pathology.swmed.edu
Subject: ASR's


Can someone clarify the regulation on ASR.s associated with primary
antibodies.  I'm still confused confused about the regulations on the
why's and when's.

Dave