[Histonet] Tests not FDA -approved / cleared

Morken, Timothy Timothy.Morken <@t> ucsfmedctr.org
Fri Jan 6 10:48:55 CST 2012

S Khan, 

I don't think it applies to special stains. I've never seen anything that said Special Stains are regulated by FDA (more correctly, the companies that sell special stains do not require FDA regulation). I guess it is because they are historically exempt or something. 

I do notice that some companies, like DAKO label their special stain kits as "IVD" but other companies do not. 

But this mainly applies to antibodies and ISH probes, so it's an interesting question for the histo lab because the vast majority of antibodies used by labs are Class I exempt IVD's or ASR's that are not "approved/cleared by FDA."  (you have to note that on your reports, but CAP has also recommended putting a second disclaimer that those antibodies do not require approval).  That is because they are officially exempt from regulation because they are considered ancillary tests that do not require FDA regulation. Vendors do not supply any test information to FDA about Class I antibodies. The IVD status simply denotes they were produced by an FDA-certified vendor and so the quality should be satisfactory.

So, what is the point of listing all those antibodies? I don't know.

On the other hand, some labs use Research Use Only (RUO) antibodies that they validate themselves. CLIA allows that though FDA and CAP discourage the practice (CLIA regulates labs, FDA regulates vendors of reagents). I think these are the ones CAP is really interested in. Maybe gathering data??

Tim Morken
Supervisor, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of shehnaz khan
Sent: Friday, January 06, 2012 7:38 AM
To: histonet <@t> lists.utsouthwestern.edu
Cc: histonet <@t> pathology.swmed.edu
Subject: [Histonet] Tests not FDA -approved / cleared

Hi netters,

Wondering what's been done for the following CAP standard (COM
40200): Tests not FDA -approved / cleared. "The lab has a list of tests not approved /cleared by FDA that have been implemented during the previous two years".

Does this apply to special stains too?

Is this applicable for IHC done manually using Dako antibodies?

Thanks in advance.

S Kahn

Chief scientist
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