ASR reagents

From:"Garza-Williams, Sara"

With CAP inspection coming up.  Can someone out in histonet world clarify
the question under ANP.12425 - If immunohistochemical studies involving
reagents labeled by the manufacturer as "analyte-specific reagents" comprise
part of the specimen evaluation, is the federally-required clarifying
statement part the report?

In your final surgical report would you include in the comment section:
(Mandatory language) "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."  Or would you use: "The
FDA has determined that such clearance or approval is not necessary.  This
test is used for clinical purposes.  It should not be regarded as
investigational or for research.  This laboratory is certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to
perform high complexity clinical laboratory testing."

I guess I'm a bit confused regarding the requirements of CAP and the vendor
(company) selling the antibody for immunohistochemical staining. Most of the
product specification sheets that I have say "For in vitro diagnostic use"
or "For research Only"  "Not for use in diagnostic procedures"

Would you include one of the above comments in the report, regardless?
Necessary to do so?
Ahh I'm confused.....................

Sara A. Williams 

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