ASR Classification and Disclaimer
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From: | "Goodwin, Diana" <DGoodwin@CHSNJ.org> |
To: | "'Histonet'" <HistoNet@pathology.swmed.edu> |
Reply-To: | |
Content-Type: | text/plain |
> ----------
> 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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