This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the addition of a new instrument platform. The devices, as modified, will be marketed under the trade name elecsys hbsag immunoassay, elecsys hbsag confirmatory test and elecsys precicontrol hbsag and is indicated: elecsys hbsag immunoassay - for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (sodium heparin, k3-edta, 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 at high risk of acquiring hbv during the perinatal period. The electrochemilumi-nescence immunoassay? Eclia? Is intended for use on the roche elecsys 2010 and modular analytics e170 (elecsys module) immunoassay analyzers. The elecsys hbsag confirmatory test - for the in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (sodium heparin, edta-k3, sodium citrate) samples repeatedly reactive when tested with the elecsys hbsag immunoassay. The elecsys hbsag confirmatory immunoassay is intended for use on the roche elecsys 2010 and modular analytics e170 immunoassay analyzers. Elecsys precicontrol hbsag - for quality control of the elecsys hbsag immunoassay on the elecsys 2010 and modular analytics e170 analyzers when testing human serum. The performance of the precicontrol hbsag has not been established with any other hbsag assay.
| Device | ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2004-09-29 |
| Decision Date | 2007-03-13 |
| PMA | P990012 |
| Supplement | S001 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0457 |
| 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 |