DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
FDA premarket approval P890064/S009 · decided 2003-03-31
Approval details
- PMA number
- P890064
- Supplement
- S009
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen Gaithersburg, Inc.
- Date received
- 2001-10-01
- Decision date
- 2003-03-31
- Days to decision
- 546 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- 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 H
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