This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the inform her2 dual ish dna probe cocktail. This device is indicated for:the inform her2 dual ish dna probe cocktail is intended for use in determining her2 gene status by enumeration of the ratio of the her2 gene to chromosome 17. The her2 and chromosome 17 probes are detected using two color chromogenic in situ hybridization (ish) in formalin-fixed. Paraffin-embedded human breast cancer tissue specimens following staining on ventana benchmark xt automated slide stainers (using nexes software), by light microscopy. The inform her2 dual ish dna probe cocktail is indicated as an aid in the assessment of patients for whom i-herpceptin (trastuzumab) treatment is being considered. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls. This reagent is intended for in vitro diagnostic (ivd) use.
| Device | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL |
| Classification Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2010-07-12 |
| Decision Date | 2011-06-14 |
| Notice Date | 2011-06-15 |
| PMA | P100027 |
| Supplement | S |
| Product Code | NYQ |
| Docket Number | 11M-0472 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100027 | Original Filing | |
| S038 | 2022-10-14 | 30-day Notice |
| S037 | 2022-07-12 | 30-day Notice |
| S036 | 2022-02-16 | Special (immediate Track) |
| S035 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S034 | 2021-02-22 | Real-time Process |
| S033 | 2020-08-26 | Real-time Process |
| S032 | 2020-01-13 | Real-time Process |
| S031 | 2019-08-22 | Real-time Process |
| S030 | 2019-02-13 | Normal 180 Day Track |
| S029 | 2018-06-18 | Real-time Process |
| S028 | ||
| S027 | 2017-07-17 | 30-day Notice |
| S026 | 2016-11-15 | Normal 180 Day Track |
| S025 | 2016-11-04 | 30-day Notice |
| S024 | 2015-12-10 | 135 Review Track For 30-day Notice |
| S023 | 2015-08-26 | 30-day Notice |
| S022 | 2015-08-14 | 30-day Notice |
| S021 | 2015-02-11 | 30-day Notice |
| S020 | 2014-10-27 | 30-day Notice |
| S019 | 2014-06-16 | 135 Review Track For 30-day Notice |
| S018 | 2014-05-01 | Real-time Process |
| S017 | 2014-02-06 | Real-time Process |
| S016 | 2014-01-22 | Real-time Process |
| S015 | 2014-01-06 | 30-day Notice |
| S014 | 2013-12-27 | 30-day Notice |
| S013 | 2013-11-12 | 30-day Notice |
| S012 | 2013-10-28 | 30-day Notice |
| S011 | 2013-09-12 | 30-day Notice |
| S010 | 2013-05-07 | 30-day Notice |
| S009 | 2013-05-06 | Real-time Process |
| S008 | 2013-04-17 | 30-day Notice |
| S007 | 2013-03-12 | Real-time Process |
| S006 | 2013-03-04 | 30-day Notice |
| S005 | 2012-10-10 | Normal 180 Day Track |
| S004 | 2012-09-26 | Real-time Process |
| S003 | 2012-08-31 | Real-time Process |
| S002 | 2011-09-19 | Normal 180 Day Track |
| S001 | 2011-08-29 | Real-time Process |