PMA P890064S009
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S009
- Product code
- MAQ
- Decision date
- 2003-03-31
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR THE DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST. THE DEVICE IS INDICATED FOR: 1) TO SCREEN PATIENTS WITH ASCUS (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) PAP SMEAR RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY. 2) IN WOMEN 30 YEARS AND OLDER THE HC2 HIGH-RISK HPV DNA TEST CAN BE USED WITH PAP TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P890064S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
- Applicant
- Qiagen Gaithersburg, Inc.
- PMA number
- P890064
- Supplement
- S009
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2003-03-31
- Decision code
- APPR
- Date received
- 2001-10-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST. THE DEVICE IS INDICATED FOR: 1) TO SCREEN PATIENTS WITH ASCUS (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) PAP SMEAR RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY. 2) IN WOMEN 30 YEARS AND OLDER THE HC2 HIGH-RISK HPV DNA TEST CAN BE USED WITH PAP TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.