Approval for migration of the architect® core¿ assay to a newarchitect® i system family member, the architect® i 1000sr. The architect core reagent kit device is indicated for:the architect core assay is a chemiluminescent microparticle immunoassay(cmia) for the qualitative detection of igg and igm antibodies to hepatitis b coreantigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information.
| Device | ABBOTT ARCHITECT CORE ASSAY |
| 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 |
| Date Received | 2009-06-19 |
| Decision Date | 2009-12-10 |
| PMA | P080023 |
| Supplement | S001 |
| 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. ap5n-2, Dept. 09vb abbott Park, IL 60064 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080023 | | Original Filing |
| S039 |
2023-01-06 |
30-day Notice |
| S038 |
2022-09-27 |
30-day Notice |
| S037 |
2022-09-14 |
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 |
2020-03-16 |
Normal 180 Day Track No User Fee |
| S032 |
2020-03-16 |
Normal 180 Day Track No User Fee |
| S031 | | |
| S030 |
2018-10-12 |
30-day Notice |
| S029 |
2018-07-13 |
30-day Notice |
| S028 |
2017-12-21 |
Normal 180 Day Track |
| S027 |
2015-07-16 |
30-day Notice |
| S026 |
2014-11-13 |
30-day Notice |
| S025 |
2014-09-19 |
30-day Notice |
| S024 |
2013-10-30 |
30-day Notice |
| S023 |
2013-10-28 |
30-day Notice |
| S022 |
2013-09-04 |
30-day Notice |
| S021 |
2013-02-15 |
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 |
2012-03-22 |
30-day Notice |
| S013 |
2012-03-15 |
30-day Notice |
| S012 |
2011-11-23 |
Special (immediate Track) |
| S011 |
2011-10-28 |
135 Review Track For 30-day Notice |
| S010 |
2011-10-28 |
30-day Notice |
| S009 |
2011-05-25 |
30-day Notice |
| S008 |
2011-05-04 |
Normal 180 Day Track No User Fee |
| S007 |
2011-04-18 |
30-day Notice |
| S006 |
2011-02-17 |
Normal 180 Day Track No User Fee |
| S005 |
2010-12-28 |
135 Review Track For 30-day Notice |
| S004 |
2010-12-22 |
Special (immediate Track) |
| S003 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S002 |
2010-06-22 |
Normal 180 Day Track No User Fee |
| S001 |
2009-06-19 |
Normal 180 Day Track |
NIH GUDID Devices