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.
| Device | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 2001-10-01 |
| Decision Date | 2003-03-31 |
| Notice Date | 2004-04-01 |
| PMA | P890064 |
| Supplement | S009 |
| Product Code | MAQ |
| Docket Number | 04M-0147 |
| Advisory Committee | Microbiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GAITHERSBURG, INC 1900 Germantown Road germantown, MD 20874 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P890064 | | Original Filing |
| S041 |
2020-05-20 |
30-day Notice |
| S040 |
2018-02-28 |
30-day Notice |
| S039 |
2018-02-16 |
30-day Notice |
| S038 |
2018-02-16 |
30-day Notice |
| S037 |
2018-01-26 |
30-day Notice |
| S036 |
2018-01-11 |
30-day Notice |
| S035 |
2017-11-30 |
30-day Notice |
| S034 |
2017-06-29 |
30-day Notice |
| S033 |
2016-02-19 |
Real-time Process |
| S032 |
2015-04-28 |
Normal 180 Day Track No User Fee |
| S031 |
2014-09-23 |
Real-time Process |
| S030 |
2014-03-21 |
Real-time Process |
| S029 |
2013-08-15 |
Normal 180 Day Track No User Fee |
| S028 | | |
| S027 |
2011-07-28 |
Normal 180 Day Track No User Fee |
| S026 |
2011-02-28 |
Real-time Process |
| S025 |
2011-02-28 |
30-day Notice |
| S024 |
2010-04-15 |
30-day Notice |
| S023 |
2010-04-15 |
30-day Notice |
| S022 |
2010-04-15 |
30-day Notice |
| S021 |
2010-02-03 |
Normal 180 Day Track No User Fee |
| S020 |
2008-01-29 |
Normal 180 Day Track No User Fee |
| S019 | | |
| S018 |
2006-03-24 |
Real-time Process |
| S017 |
2004-11-19 |
Special (immediate Track) |
| S016 | | |
| S015 |
2004-05-28 |
Real-time Process |
| S014 |
2003-11-05 |
Normal 180 Day Track |
| S013 |
2003-10-01 |
Real-time Process |
| S012 |
2003-05-20 |
Special (immediate Track) |
| S011 | | |
| S010 | | |
| S009 |
2001-10-01 |
Panel Track |
| S008 |
2000-08-25 |
Normal 180 Day Track |
| S007 |
2000-02-07 |
Normal 180 Day Track |
| S006 |
1997-09-30 |
Normal 180 Day Track |
| S005 |
1996-11-01 |
Normal 180 Day Track |
| S004 |
1996-05-03 |
Normal 180 Day Track |
| S003 |
1993-09-27 |
Normal 180 Day Track |
| S002 |
1992-12-09 |
Normal 180 Day Track |
| S001 |
1991-10-18 |
Normal 180 Day Track |
NIH GUDID Devices