Approval for the pathvysion her-2 dna probe kit. This device is indicated to detect amplification of the her-2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the pathvysion kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage ii, node-positive breast cancer patients. The pathvysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage ii, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (caf) chemotherapy. The pathvysion kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
| Device | PATHVYSION HER-2 DNA PROBE KIT |
| Classification Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2001-03-30 |
| Decision Date | 2001-12-31 |
| Notice Date | 2002-04-25 |
| PMA | P980024 |
| Supplement | S001 |
| Product Code | MVD |
| Docket Number | 02M-0172 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980024 | | Original Filing |
| S022 |
2022-02-18 |
30-day Notice |
| S021 |
2020-11-16 |
30-day Notice |
| S020 |
2019-04-10 |
30-day Notice |
| S019 |
2018-08-10 |
30-day Notice |
| S018 |
2018-06-15 |
30-day Notice |
| S017 |
2018-02-16 |
30-day Notice |
| S016 |
2017-11-08 |
30-day Notice |
| S015 |
2016-09-02 |
30-day Notice |
| S014 |
2016-06-01 |
30-day Notice |
| S013 |
2014-06-16 |
30-day Notice |
| S012 |
2013-11-25 |
30-day Notice |
| S011 |
2013-11-05 |
30-day Notice |
| S010 |
2013-01-16 |
30-day Notice |
| S009 |
2012-11-15 |
30-day Notice |
| S008 |
2012-06-21 |
Special (immediate Track) |
| S007 |
2012-06-14 |
135 Review Track For 30-day Notice |
| S006 |
2011-10-17 |
135 Review Track For 30-day Notice |
| S005 |
2011-02-22 |
135 Review Track For 30-day Notice |
| S004 |
2010-12-22 |
30-day Notice |
| S003 |
2009-01-15 |
30-day Notice |
| S002 |
2005-06-20 |
Normal 180 Day Track No User Fee |
| S001 |
2001-03-30 |
Panel Track |
NIH GUDID Devices