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2007P-0210
CCP 1
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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