Diana,

We do specify our catagorization of antibodies (e.g. ASR) in our 2000
catalog. Also, on the inside of the front cover of this catalog, we have an
"easy read" summary of the FDA final rule. The catalog also includes a copy
of the validation form that we use and this may be helpful to you in
respect to your lab's documentation of validation tests. Note that I say
"catagorization" as opposed to "classification." The reason for this is
made apparent in that "easy read" description I referred to earlier.

Please let us know if we can be of further assistance.

Regards,
Paul Ardi
Cell Marque Corp.
800-665-7284

At 02:13 PM 05/02/2000 -0400, you wrote:
>
>
>> ----------
>> 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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