Approval for the architect core-m reagent kitarchitect core-m calibrators andarchitect core-m controls. The devices is indicted for: the architect core-m assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of igm antibody to hepatitis b core antigen (igm anti-hbc) in human adult and pediatric serum or plasma (dipotassium edta, lithium heparin, and sodium heparin) and neonatal serum. A test for igm anti-hbc is indicated as an aid in the diagnosis of acute or recent hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. The architect core-m calibrators are used for the calibration of the architect i system when the system is used for the qualitative detection of igm antibody to hepatitis b core antigen (igm anti-hbc) using the architect core-m reagent kit. The performance of the architect core-m calibrators has not been established with any other igm anti-hbc assays. The architect core-m controls are used for monitoring the performance of the architect i system when used for the qualitative detection of igm antibody to hepatitis b core antigen (igm anti-hbc) in human adult serum and plasma when using the architect core-m reagent kit. The performance of the architect core-m controls has not been established with any other igm anti-hbc assays.
| Device | ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/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 | 2006-12-01 |
| Decision Date | 2007-11-06 |
| Notice Date | 2007-11-19 |
| PMA | P060035 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0447 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 100 Abbott Park Rd. ap5n-2, Dept. 09vb abbott Park, IL 60064-3500 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060035 | | Original Filing |
| S037 |
2023-01-06 |
30-day Notice |
| S036 |
2022-09-27 |
30-day Notice |
| S035 |
2022-09-14 |
30-day Notice |
| S034 |
2021-11-18 |
30-day Notice |
| S033 |
2021-11-09 |
30-day Notice |
| S032 |
2021-02-09 |
Real-time Process |
| S031 | | |
| S030 |
2020-03-16 |
Normal 180 Day Track No User Fee |
| S029 |
2020-03-16 |
Normal 180 Day Track No User Fee |
| S028 | | |
| S027 |
2018-10-22 |
30-day Notice |
| S026 |
2018-06-01 |
Normal 180 Day Track |
| S025 |
2015-07-16 |
30-day Notice |
| S024 |
2014-11-13 |
30-day Notice |
| S023 |
2014-09-19 |
30-day Notice |
| S022 |
2013-10-30 |
30-day Notice |
| S021 |
2013-10-28 |
30-day Notice |
| S020 |
2013-02-15 |
30-day Notice |
| S019 |
2013-02-11 |
30-day Notice |
| S018 |
2012-11-19 |
30-day Notice |
| S017 |
2012-11-15 |
30-day Notice |
| S016 |
2012-11-13 |
30-day Notice |
| S015 |
2012-11-01 |
30-day Notice |
| S014 |
2012-08-03 |
30-day Notice |
| S013 |
2011-11-23 |
Special (immediate Track) |
| S012 |
2011-10-28 |
30-day Notice |
| S011 |
2011-10-28 |
135 Review Track For 30-day Notice |
| S010 |
2011-09-07 |
Special (immediate Track) |
| 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 |
2011-01-10 |
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 |
2010-08-02 |
Normal 180 Day Track No User Fee |
| S001 |
2009-01-08 |
Normal 180 Day Track |
NIH GUDID Devices