Approval for migration of the cervista hpv hr manual assay to an automated platform high-throughput automation. The device, as modified, will be marked under trade name cervista hpv hr high-throughput automation and is indicated for:the cervista hpv hr test is an in vitro diagnostic test for the qualitative detection of dna from 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 the specific hpv type present. The cervista hpv hr test uses the invader chemistry, a signal amplification method for detection 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 colostomy; and 2) in women 30 years and older the cervista hpv hr test can be used with cervical cytology 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. Cervical specimens that may be tested with the cervista hpv hr test include the following preservation system collection media and collection devices:¿ thinprep pap test preservcyt solution¿ broom-type device (e. G. , rovers cervex brush, wallach papette), or endocervical brush/spatula. The cervista hpv hr test may be performed either manually or using the automated cervista high-throughput automation system. (corrected statement needs to be added to database. )
| Device | CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | HOLOGIC, INC. |
| Date Received | 2011-04-27 |
| Decision Date | 2011-12-12 |
| PMA | P080014 |
| Supplement | S007 |
| 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 | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01750 |
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