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 abbott axsym hbsag assay, which is indicated for: axsym hbsag: axsym hbsag is a microparticle enzyme immunoassay (meia) intended for the qualitative detection of hepatitis b surface antigen (hbsag) in neonatal serum, and 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). The assay is used as an aid in the diagnosis of acute or chronic hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. The assay may be used to test for hbv infection in pregnant women. Axsym hbsag confirmatory: axsym hbsag confirmatory in s microparticle enzyme immunoassay (meia) intended for the confirmation of the presence of hepatitis b surface antigen (hbsag) in neonatal serum, and 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). The assay is used for confirmation of samples found to be repeatedly reactive by the axsym hbsag assay. The assay may be used to confirm hepatitis b virus (hbv) infection in pregnant woman. Axsym hbsag controls: the axsym hbsag positive and negative controls are for use in monitoring the performance of the axsym hbsag reagent kit and the axsym hbsag confirmatory kit. The performance of the axsym hbsag controls have not been established with any other hbsag assays.
| Device | AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2005-12-06 |
| Decision Date | 2006-06-01 |
| Notice Date | 2007-05-03 |
| PMA | P050049 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0174 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap8-1 abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050049 | Original Filing | |
| S011 | 2012-11-13 | 30-day Notice |
| S010 | 2012-02-06 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-08-01 | 135 Review Track For 30-day Notice |
| S007 | 2011-06-10 | 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 | 2008-10-24 | Real-time Process |
| S002 | 2007-12-13 | Special (immediate Track) |
| S001 | 2007-01-17 | 30-day Notice |