Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for:architect core reagent kit: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. Architect core calibrator:the architect core calibrator is used for the calibration of the architect isystem when the system is used for the qualitative detection of igg and igm antibodies tohepatitis b core antigen (anti-hbc) with the architect core reagent kit. The performance of the architect core calibrator has not been established with any other anti-hbc assays. Architect core controls:the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. Theperformance of the architect core controls has not been established with any otheranti-hbc assays.
| Device | ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE 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 |
| Date Received | 2008-08-28 |
| Decision Date | 2009-04-10 |
| Notice Date | 2009-05-27 |
| PMA | P080023 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 09M-0244 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 100 Abbott Park Rd. ap5n-2, Dept. 09vb abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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