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 re-standardization of the assay to the who 2nd international standard and changes to the dilution protocol for the abbott architect ausab which uses a new component, the architect ausab specimen diluent.
| Device | ABBOTT ARCHITECT AUSAB |
| 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 | 2016-08-22 |
| Decision Date | 2016-12-09 |
| PMA | P050051 |
| Supplement | S032 |
| 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 |