Liz, You are correct. If you bring in an FDA-approved test with NO modifications, all that is required is verification; you simply have to verify that the test works in your lab when you follow the recommended procedure. Validation, which is required for laboratory-developed tests as well as laboratory-modified FDA-approved tests, is, indeed, a much lengthier process.
Stephanie Rodriguez, HTL(ASCP), QIHC Lead Molecular Technologist-FISH IHC Technologist III Phenopath Laboratories Seattle, WA (206) 374-9000 On 9/27/11 9:49 AM, "histonet-requ...@lists.utsouthwestern.edu" <histonet-requ...@lists.utsouthwestern.edu> wrote: >Message: 8 >Date: Tue, 27 Sep 2011 10:32:07 -0600 >From: Elizabeth Chlipala <l...@premierlab.com> >Subject: RE: [Histonet] Xylene sensitivity >To: 'Rene J Buesa' <rjbu...@yahoo.com>, "Histonet Listserv (E-mail)" > <histonet@lists.utsouthwestern.edu>, ShelleyD'Attilio > <sdatt...@stormontvail.org>, Loralee AMcMahon > <loralee_mcma...@urmc.rochester.edu> >Message-ID: > <14E2C6176416974295479C64A11CB9AE1DECBA0A63@SBS2K8.premierlab.local> >Content-Type: text/plain; charset="iso-8859-1" > >Rene > >Rene > >Loralee is correct in some aspects and you have addressed this already >with mentioning validation. This basically has to do with the internal >validation that is required when you bring these kits into the >laboratory. When you modify a 510K cleared kit or FDA approved kit it >becomes a LDT or Laboratory Developed Test there is significant >additional validation required because by changing the process you have >essentially increased the risk. Additional validation is required as >defined by CLIA. The manufacturer of the kit has gone through a process >that essentially has decreased the laboratory risk when then get a kit >FDA cleared or approved, if the lab chooses to modify this kit they >essentially have increased their risk significantly and are required to >do additional validation, more than would be required if you used the kit >as recommended. > >I'm thinking that all that is required if you use a cleared or approved >kit is verification and not validation, but I may be incorrect. >Validation is a more intense process. Patty from Phenopath or Beth >Shepard from Ventana would be able to comment on this process also. > >Liz > >Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC >Manager >Premier Laboratory, LLC >PO Box 18592 >Boulder, CO 80308-1592 >(303) 682-3949 office >(303) 682-9060 fax >(303) 881-0763 cell >www.premierlab.com > >Ship to address: > >1567 Skyway Drive, Unit E >Longmont, CO 80504 This e-mail message, including any attachments, is for the sole use of the intended recipients and may contain privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail and destroy all copies of the original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. at (206) 374-9000. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet