Approval for the manufacturing change to components of the probechek her-2/neu cutoff control slides used in the pathvysion her-2 dna probe kit. The change included creation of a new master cell bank and a new working cell bank from seed stock of hs578t cells, used in the manufacture of the probechek her-2/neu cutoffcontrol slides.
| Device | PATH VYSION HER-2 DNA PROBE KIT ASSAY |
| 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 | 2012-06-14 |
| Decision Date | 2012-12-20 |
| PMA | P980024 |
| Supplement | S007 |
| Product Code | MVD |
| Advisory Committee | Pathology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
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