Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | QIAGEN GAITHERSBURG, INC 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P890064 |
Supplement Number | S009 |
Date Received | 10/01/2001 |
Decision Date | 03/31/2003 |
Product Code |
MAQ |
Docket Number | 04M-0147 |
Notice Date | 04/01/2004 |
Advisory Committee |
Microbiology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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