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 elecsys. Hbsag immunoassay, elecsys hbsag confirmatory, and precicontrol hbsag. The devices are indicated for: elecsys hbsag immunoassay is an immunoassay for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (heparin, edta-k3, sodium citrate). Assay results in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. The electrochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys 2010 immunoassay system. Elecsys hbsag confirmatory is an immunoassay for the in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (heparin, edta-k3, sodium citrate) samples repeatedly reactive when tested with elecsys 2010 hbsag immunoassay. Precicontrol hbsag is used for quality control of the elecsys hbsag immunoassay on the elecsys 2010 immunoassay system when testing human serum. The performance of the precicontrol hbsag has not been established with any other hbsag assay.
| Device | ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG |
| 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 | ROCHE DIAGNOSTICS CORP. |
| Date Received | 1999-03-04 |
| Decision Date | 2001-06-01 |
| Notice Date | 2001-11-14 |
| PMA | P990012 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 01M-0507 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0457 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990012 | Original Filing | |
| S033 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S032 | 2018-04-17 | Real-time Process |
| S031 | 2018-03-01 | Real-time Process |
| S030 | ||
| S029 | 2017-10-11 | Real-time Process |
| S028 | 2017-08-03 | 30-day Notice |
| S027 | 2016-10-26 | 30-day Notice |
| S026 | 2016-02-16 | 30-day Notice |
| S025 | 2016-01-27 | 30-day Notice |
| S024 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S023 | 2015-10-07 | 30-day Notice |
| S022 | 2014-11-25 | 30-day Notice |
| S021 | 2014-04-04 | Real-time Process |
| S020 | 2013-04-09 | Real-time Process |
| S019 | 2012-11-30 | 30-day Notice |
| S018 | 2012-10-04 | 30-day Notice |
| S017 | 2012-10-04 | 30-day Notice |
| S016 | 2012-10-03 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2012-02-29 | 30-day Notice |
| S013 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S012 | 2011-10-11 | Normal 180 Day Track |
| S011 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S010 | 2011-08-17 | 135 Review Track For 30-day Notice |
| S009 | 2011-05-17 | Normal 180 Day Track No User Fee |
| S008 | 2011-04-11 | 30-day Notice |
| S007 | 2008-09-02 | 30-day Notice |
| S006 | 2008-04-30 | Normal 180 Day Track |
| S005 | 2007-09-04 | Normal 180 Day Track |
| S004 | ||
| S003 | 2005-10-14 | Special (immediate Track) |
| S002 | 2005-08-02 | 135 Review Track For 30-day Notice |
| S001 | 2004-09-29 | Normal 180 Day Track |