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 ausab assay. The device is indicated for: axsym ausab reagent pack is a microparticle enzyme immunoassay (meia) intended for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in sodium heparin). The assay is used for the quantitative measurement of antibody response to hepatitis b virus (hbv) vaccination for the determination of hbv immune status, and for the diagnosis of hbv disease associated with hbv infection when used in conjunction with other laboratory results and clinical information. The axsym ausab standard calibrators are used for the calibration of the axsym system when the system is used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) using the axsym ausab reagent pack. The performance of the axsym ausab standard calibrators has not been established with any other anti-hbs assays. The axsym ausab controls are used for monitoring the performance of the axsym system (reagent, calibrators, and instrument) when used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) when using the axsym ausab reagent pack. The performance of the axsym ausab controls has not been established with any other anti-hbs assays.
| Device | AXSYM, AUSAB |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2006-02-10 |
| Decision Date | 2006-08-07 |
| Notice Date | 2007-04-30 |
| PMA | P060003 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0161 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road dept 9va- Ap5-2 abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060003 | Original Filing | |
| S012 | 2012-11-13 | 30-day Notice |
| S011 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S010 | 2011-09-06 | 30-day Notice |
| S009 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S008 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S007 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S006 | 2010-09-27 | 30-day Notice |
| S005 | 2010-06-11 | Real-time Process |
| S004 | 2009-02-17 | 30-day Notice |
| S003 | 2007-01-17 | 30-day Notice |
| S002 | 2006-09-05 | 30-day Notice |
| S001 | 2006-08-15 | 30-day Notice |