Approval for the cervista hpv hr and genfind dna extraction kit. Cervista hpv hr indications for use: the cervista hpv hr test is an in vitro diagnostic test for the qualitative detection of dnafrom 14 high-risk- human papillomavirus (hpv) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,59, 66, and 68) in cervical specimens. The cervista hpv hr test cannot determine thespecific hpv type present. The cervista hpv hr test uses the invader chemistry, a signal amplification method fordetection of specific nucleic acid sequences. This method uses two types of isothermal reactions:a primary reaction that occurs on the targeted dna sequence and a secondary reaction that produces a fluorescent signal. The cervista hpv hr test is indicated:1) to screen patients with atypical squamous cells of undetermined significance (ascus)cervical cytology results to determine the need for referral to colposcopy. 2) in women 30 years and older the cervista hpv hr test can be used with cervicalcytology to adjunctively screen to assess the presence or absence of high-risk hpvtypes. This information, together with the physician's assessment of cytology history,other risk factors, and professional guidelines, may be used to guide patientmanagement. Cervical specimens that may be tested with the cervista hpv hr test include the followingpreservation system collection media and collection devices:¿ thinprep pap test preservcyt solution¿ broom-type device (e. G. Rovers cervex brush, wallach papette), or endocervicalbrush/spatula. Genfind dna extraction kit indication for use:the genfind dna extraction kit is intended for use in the extraction of dna fromcervical specimens collected in thinprep pap test preservcyt solution for testingby the cervista hpv hr and cervista hpv 16/18 tests.
| Device | CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | HOLOGIC, INC. |
| Date Received | 2008-04-28 |
| Decision Date | 2009-03-12 |
| Notice Date | 2009-06-30 |
| PMA | P080014 |
| Supplement | S |
| Product Code | MAQ |
| Docket Number | 09M-0299 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01750 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080014 | | Original Filing |
| S024 |
2018-10-16 |
30-day Notice |
| S023 |
2018-09-10 |
30-day Notice |
| S022 |
2018-08-31 |
30-day Notice |
| S021 |
2018-07-18 |
30-day Notice |
| S020 |
2013-11-08 |
30-day Notice |
| S019 |
2013-08-02 |
Normal 180 Day Track No User Fee |
| S018 |
2013-07-31 |
Normal 180 Day Track No User Fee |
| S017 |
2013-07-24 |
30-day Notice |
| S016 |
2012-12-20 |
Real-time Process |
| S015 |
2012-12-19 |
Real-time Process |
| S014 |
2012-11-13 |
30-day Notice |
| S013 |
2012-06-11 |
30-day Notice |
| S012 |
2012-04-17 |
Real-time Process |
| S011 |
2012-01-09 |
Real-time Process |
| S010 |
2011-12-28 |
30-day Notice |
| S009 |
2011-07-07 |
30-day Notice |
| S008 |
2011-06-02 |
30-day Notice |
| S007 |
2011-04-27 |
Normal 180 Day Track |
| S006 |
2010-12-30 |
30-day Notice |
| S005 |
2010-10-21 |
Real-time Process |
| S004 |
2010-10-05 |
30-day Notice |
| S003 |
2010-09-16 |
Real-time Process |
| S002 |
2010-06-03 |
30-day Notice |
| S001 |
2009-06-24 |
30-day Notice |
NIH GUDID Devices