Re: Disclaimers on reports for the ASR changes?

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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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The key to the whole issue is how the manufacturer labels the antibodies being
used.  If the label clearly states the antibody is an IVD, no disclaimer is
necessary.  If the antibody is clearly labeled as an ASR, the disclaimer is
required under the new regulation, and FDA can potentially come and inspect the
laboratory for the presence of such disclaimers.  FDA believes clinical
laboratories developing tests with ASRs are essentially acting as
manufacturers of
medical devices.  If the antibody is labeled solely for experimental or
use, the manufacturer cannot provide the antibody for an intended clinical use.
See Clinical Laboratory News v24 n4, pg. 10, April, 1998.

Perhaps not directly on the JCIM web site, but if you contact them, they can
provide more, current, information on the situation.

Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Ph. 1-314-615-6964; Pager: 841-9351

Nancy Shellhorn wrote:

> Dear Histonet Subscribers,
>         I have been asked this question by several customers about the
> on their reports after Nov. 23, when the new FDA ruling takes effect.
> As I understand it you do not have to put a disclaimer in your report
> unless you are dealing with a confirmatory diagnostic antibody such as
> ER/PR or c-erbB-2 which I believe will be ASR antibodies? Please e-mail
> all the users with your answers I believe everyone is anxious to hear
> about the difference and what changes are going to occur in reporting. I
> looked at the JCIM web site and it does not really address this issue.
> Any thoughts on the matter would be greatly appreciated. Thank you to
> all those in advance responding to this critical issue.
> Sincerely,
> Nancy Shellhorn
> Zymed Laboratories, Inc.
> 458 Carlton Ct.
> South San Francisco, CA  94080
> 1-800-874-4494 ext. 9002

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