Approval for chaning the solid phase on which the rna:dna hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (digene cervical sampler), addition of the digene sample conversion kit,a nd the addition of new assay performance characteristics. The device, as modified, will be marketed under the trade name digene hpv test using hybrid capture(r) ii technology (hcii hpv) witht he following indications: the digene hpv test using hybrid capture ii technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (hpv) dna in cervical specimens. The digene hpv test can differentiate between two hpv dna groups: low risk hpv types 6/11/42/43/44; and high/intermediate risk hpv types 16/18/31/33/35/39/45/51/52/56/58/59/68, but cannot determine the specific hpv type present. Cervical specimens which may be tested with the digene hpv test include the following: 1) specimens collected with the digene cervical sampler; 2) biopsies collected in the digene specimen transport medium; 3) specimens collected using a broom-type collection device and placed in cytye preservcyt solution (refer to the digen sample converstion kit package insert for complete details).
| Device | HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY) |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 1997-09-30 |
| Decision Date | 1999-03-17 |
| PMA | P890064 |
| Supplement | S006 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GAITHERSBURG, INC 1900 Germantown Road germantown, MD 20874 |
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