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Dockets Management


Volume 1

Change in Classification Petition

Attachment 1 - FDA Form 3427, Supplemental Data

Attachment 2 - FDA Form 3429 , General Device Classification Questionnaire

Attachment 3
Volume A: 513 Clinical Specimens Tested for HPV by Nested PCR/DNA Sequencing and by Digene HC2 Assay
Volume B: 107 DNA Sequencing tracings with BLAST analyses for genotyping, part 2, part 3

Reference 1 - FDA News P03-26, March 31, 2003.

Reference 2 - FDA OIVD/CDRH Letter to Ventana Medical Systems, Inc. March 18, 2004.

Reference 3 - Hojvat SA, Director, Division of Microbiology Devices. OIVD, FDA Letter dated January 9, 2007 re: K063649.

Reference 12 - Copy of October 30, 2006 letter from Dr. S. H. Lee to Dr. SI Gutman, seeking guidance to submission of a 510(k) for HPV PCR reagent.

Reference 13 - Manuscript by SH Lee et al. titled "Human Papillomavirus Genotyping by DNA Sequencing - The Gold Standard HPV Test for Patient Care.

Reference 14 - VRBPAC Background Document: GardasilT HPV Quadrivalent Vaccine. May 18, 2006 VRBPAC Meeting www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

Reference 54 - Overview of IVD Regulation, OIVD/CDRH, FDA: What is Premarket Approval (PMA)? http://www.fda.gov/cdrh/oivd/regulatory-overview.html#9

Reference 62 - www.cancer.gov/cancertopics/pdq/treatment/gastric/HealthProfessional/page1/pnnt

Reference 63 - http://www.nci.nih.gov/cancertopics/pdq/screening/cervical/HealthProfessional/page2

Reference 64 - FDA K024360 Approval Order on Immunoassay, H. Pylori Test, June 10, 2003

Reference 66 - http://www.cancer.gov/cancertopics/factsheet/Risk/HPV

All other references Published Material

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