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.
For migration of the architect hbsag qualitative, architect hbsag qualitative calibrators, architect hbsag qualitative confirmatory, and architect hbsag controls onto the alinity i analyzer. The device, as modified, will be marketed under the trade names alinity i hbsag qualitative ii reagent kit, alinity i hbsag qualitative ii calibrators, alinity i hbsag qualitative ii confirmatory reagent kit, and alinity i hbsag qualitative ii controls.
| Device | Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Abbott Laboratories |
| Date Received | 2019-08-01 |
| Decision Date | 2020-01-07 |
| PMA | P110029 |
| Supplement | S029 |
| 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 100 Abbott Park Rd. dept 09v6, Bldg. Ap5-2 abbott Park, IL 60064-6088 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110029 | Original Filing | |
| S041 | 2023-01-06 | 30-day Notice |
| S040 | 2022-11-07 | 30-day Notice |
| S039 | 2022-09-14 | 30-day Notice |
| S038 | 2022-09-09 | 30-day Notice |
| S037 | 2022-07-18 | 30-day Notice |
| S036 | 2021-11-18 | 30-day Notice |
| S035 | 2021-11-09 | 30-day Notice |
| S034 | 2021-02-09 | Real-time Process |
| S033 | 2020-07-02 | 30-day Notice |
| S032 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S031 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S030 | ||
| S029 | 2019-08-01 | Normal 180 Day Track |
| S028 | 2018-10-16 | 30-day Notice |
| S027 | 2018-06-27 | 30-day Notice |
| S026 | 2017-06-30 | Real-time Process |
| S025 | ||
| S024 | 2016-10-14 | 30-day Notice |
| S023 | 2016-03-10 | 30-day Notice |
| S022 | 2015-07-16 | 30-day Notice |
| S021 | 2015-06-15 | 30-day Notice |
| S020 | 2014-12-04 | 30-day Notice |
| S019 | 2014-11-14 | 30-day Notice |
| S018 | 2014-11-13 | 30-day Notice |
| S017 | 2014-03-18 | 30-day Notice |
| S016 | 2013-11-01 | 30-day Notice |
| S015 | 2013-10-30 | 30-day Notice |
| S014 | 2013-10-28 | 30-day Notice |
| S013 | 2013-09-24 | 30-day Notice |
| S012 | 2013-07-17 | 30-day Notice |
| S011 | 2013-02-11 | 30-day Notice |
| S010 | 2012-11-19 | 30-day Notice |
| S009 | 2012-11-15 | 30-day Notice |
| S008 | 2012-11-13 | 30-day Notice |
| S007 | 2012-11-01 | 30-day Notice |
| S006 | 2012-10-26 | 30-day Notice |
| S005 | 2012-09-17 | 30-day Notice |
| S004 | 2012-08-17 | 30-day Notice |
| S003 | 2012-08-03 | 30-day Notice |
| S002 | 2012-06-06 | 30-day Notice |
| S001 | 2012-05-01 | Normal 180 Day Track |