ASR Classification and Disclaimer

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From:"Goodwin, Diana" <>
To:"'Histonet'" <>

> ----------
> From: 	Goodwin, Diana
> Sent: 	Wednesday, April 26, 2000 10:43 AM
> To: 	'Histonet'
> Subject: 	ASR Classification and Disclaimer
> Good Morning Histonet.
> I would like to inquire as to the practice of my fellow clinical
> histopathology laboratories with regard to the required FDA disclaimer
> for Analyte Specific Reagents (ASR) on surgical pathology reports.
> I understand that it is the manufacturer who classifies the IHC
> reagents, 
> including primary antibodies.  Upon examination of the spec sheets for
> the antibodies that we currently use in our lab, NONE of them,
> including the prognostic markers, (ER, PR, Ki-67, or Cerb-B2) make any
> mention of classification or status.
> Upon looking over the new Dako, catalog, however, I noticed a "Status"
> column with a current/intended classification along with a note
> stating the company's "intention to comply with the FDA regulations on
> IVD or ASR labeling."   A significant number of their antibodies
> listed "ASR" under the intended status.  The current spec sheets for
> these antibodies, however, DO NOT mention ASR.
> So here is my question:
> 1.  What is everyone doing as far as the disclaimer is concerned?
> 2.  Am I required to post a disclaimer if no mention of ASR
> classification is      made on the Ab spec sheet?
> 3.  Would it be safer to post a disclaimer on ALL surgical reports for
> cases that have required IHC studies?
> Thanks in advance for your input.
> Diana Goodwin,  HT
> Trenton,  NJ

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