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 to extend the application of the architect ausab assay, currently approved for use on the abbott architect i2000/ i 2000sr, onto a new architect i system family member, the architect i 1000sr. Architect ausab reagent kit on architect i 1000sr:the architect ausab assay is a chemiluminescent microparticle immunoassay(cmia) for the quantitative determination of antibody to hepatitis b surface antigen(anti-hbs) in human adult and pediatric serum and plasma (dipotassium edta, lithiumheparin, and sodium heparin) and neonatal serum. It is intended for quantitativemeasurement of antibody response following hepatitis b virus (hbv) vaccination,determination of hbv immune status, and for the laboratory diagnosis of hbv diseaseassociated with hbv infection when used in conjunction with other laboratory results and clinical information. Architect ausab calibrators on architect i 1000sr:the architect ausab calibrators are used to calibrate the architect i system when the system is used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the architect ausab reagent kit. The performance of the architect ausab calibrators has not been established with anyother anti-hbs assay. Architect ausab controls on architect i 1000sr:the architect ausab controls are used for monitoring the performance of thearchitect i system when used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the architect ausab reagent kit. Theperformance of the architect ausab controls has not been established with anyother anti-hbs assay.
| Device | ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM |
| 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 | 2009-02-12 |
| Decision Date | 2009-07-23 |
| PMA | P050051 |
| Supplement | S004 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |