Approval for thecervista hpv 16/18. Cervista hpv 16/18 indications for use:the cervista hpv 16/18 test is an in vitro diagnostic test for the qualitative detection of dna from human papillomavirus (hpv) type 16 and type 18 in cervical specimens. The cervista hpv 16/18 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. Cervista hpv 16/18 test is indicated:1) in women 30 years and older the cervista hpv 16/1s test can be used adjunctivelywith the cervista hpv hr test in combination with cervical cytology to screen to assess the presence or absence of high-risk hpv types 16 and 18. This information,together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. 2) to be used adjunctively with the cervista hpv hr test in patients with atypicalsquamous cells of undetermined significance (asc-us) cervical cytology results, toassess the presence or absence of high-risk hpv types 16 and 18. This information,together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. Cervical specimens that may be tested with the cervista hpv 16/18 test include the followingpreservation system and collection devices:thinprep pap test preservcyt solution; and¿ broom-type device (e. G. Rovers cervex brush, wallach papette), or endocervicalbrush/spatula.
| Device | CERVISTA HPV 16/18 |
| 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 | P080015 |
| 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 01752 |
| 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 |
|---|
| P080015 | | Original Filing |
| S016 |
2018-10-16 |
30-day Notice |
| S015 |
2018-09-10 |
30-day Notice |
| S014 |
2018-08-31 |
30-day Notice |
| S013 |
2018-07-18 |
30-day Notice |
| S012 |
2015-04-30 |
30-day Notice |
| S011 |
2013-11-08 |
30-day Notice |
| S010 |
2013-08-02 |
Normal 180 Day Track No User Fee |
| S009 |
2013-07-31 |
Normal 180 Day Track No User Fee |
| S008 |
2012-06-11 |
30-day Notice |
| S007 |
2012-04-17 |
Real-time Process |
| S006 |
2012-01-09 |
Real-time Process |
| S005 |
2011-07-07 |
30-day Notice |
| S004 |
2011-06-02 |
30-day Notice |
| S003 |
2011-01-18 |
Real-time Process |
| S002 |
2010-11-29 |
Real-time Process |
| S001 |
2010-06-03 |
30-day Notice |
NIH GUDID Devices