This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for migration of the architect ausab assay, architect ausab calibrators and architect ausab controls onto the alinity i analyzer. The manufacture of the alinity i analyzer would be done at a new contract manufacturer, sanmina, singapore.
| Device | Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2017-12-21 |
| Decision Date | 2019-03-06 |
| PMA | P050051 |
| Supplement | S033 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap8-1 abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050051 | Original Filing | |
| S049 | 2023-01-06 | 30-day Notice |
| S048 | 2022-11-07 | 30-day Notice |
| S047 | 2022-09-14 | 30-day Notice |
| S046 | 2022-09-09 | 30-day Notice |
| S045 | 2021-11-18 | 30-day Notice |
| S044 | 2021-11-09 | 30-day Notice |
| S043 | ||
| S042 | 2021-08-11 | 30-day Notice |
| S041 | 2021-02-09 | Real-time Process |
| S040 | 2020-10-16 | 30-day Notice |
| S039 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S038 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S037 | ||
| S036 | 2019-11-04 | 30-day Notice |
| S035 | 2019-06-10 | 30-day Notice |
| S034 | 2018-10-16 | 30-day Notice |
| S033 | 2017-12-21 | Normal 180 Day Track |
| S032 | 2016-08-22 | Normal 180 Day Track |
| S031 | 2016-06-14 | 30-day Notice |
| S030 | 2015-07-16 | 30-day Notice |
| S029 | 2014-12-04 | 30-day Notice |
| S028 | 2014-11-13 | 30-day Notice |
| S027 | 2014-10-03 | 30-day Notice |
| S026 | 2014-03-18 | 30-day Notice |
| S025 | 2013-12-20 | 30-day Notice |
| S024 | 2013-10-30 | 30-day Notice |
| S023 | 2013-10-28 | 30-day Notice |
| S022 | 2013-09-24 | 30-day Notice |
| S021 | 2013-06-21 | 30-day Notice |
| S020 | 2013-02-11 | 30-day Notice |
| S019 | 2012-11-19 | 30-day Notice |
| S018 | 2012-11-15 | 30-day Notice |
| S017 | 2012-11-13 | 30-day Notice |
| S016 | 2012-11-01 | 30-day Notice |
| S015 | 2012-08-03 | 30-day Notice |
| S014 | 2011-11-23 | Special (immediate Track) |
| S013 | 2011-05-25 | 30-day Notice |
| S012 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S011 | 2011-04-18 | 30-day Notice |
| S010 | 2011-02-25 | 30-day Notice |
| S009 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S008 | 2010-12-22 | Special (immediate Track) |
| S007 | 2010-11-22 | Normal 180 Day Track No User Fee |
| S006 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S005 | 2010-08-23 | Normal 180 Day Track No User Fee |
| S004 | 2009-02-12 | Normal 180 Day Track |
| S003 | 2008-09-29 | Real-time Process |
| S002 | 2007-10-19 | Real-time Process |
| S001 | 2006-06-15 | 135 Review Track For 30-day Notice |