This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the axsym core 2. 0 and axsym core 2. 0 controls. This device is indicated for: the axsym core 2. 0 is a microparticle enzyme immunoassay (meia) intended for the qualitative detection of total antibodies (igg and igm) to hepatitis b virus core antigen (anti hbc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium edta, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin). The assay is used 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. The the axsym core 2. 0 controls are used for monitoring the performance of the axsym system (reagent and instrument) when used for the qualitative detection of total antibodies to hepatitis b virus core antigen (anti hbc) when using the axsym core 2. 0 reagent kit. The performance of the axsym core 2. 0 controls has not been established with any other anti-hbc assays.
| Device | AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2006-03-24 |
| Decision Date | 2006-09-08 |
| Notice Date | 2007-04-19 |
| PMA | P060012 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0153 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept. 09vb abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060012 | Original Filing | |
| S010 | 2012-11-13 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-09-07 | Special (immediate Track) |
| S007 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S006 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S005 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S004 | 2010-09-27 | 30-day Notice |
| S003 | 2010-09-21 | 30-day Notice |
| S002 | 2010-05-19 | 30-day Notice |
| S001 | 2007-01-17 | 30-day Notice |