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 anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm for use on the cobas e 411 immunoassay analyzer. The device is indicated for: elecsys anti-hbc igm immunoassay, the elecsys anti-hbc igm immunoassay is intended for the in vitro qualitative determination of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, lithium heparin, sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The presence of anti-hbc igm, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis b virus (hbv) infection. The elecsys anti-hbc igm immunoassays performance has not been established for the monitoring of hbv disease or therapy. The electrochemiluminescence immunoassay eclia is intended for use on the cobas e 411 immuoassay analyzer. Elecsys precicontrol anti-hbc igm - the elecsys precicontrol anti-hbc igm is used for the quality control of the elecsys anti-hbc igm immunoassay on the cobas e 411 immunoassay analyzer.
| Device | ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM |
| 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 | 2011-07-29 |
| Decision Date | 2012-01-03 |
| Notice Date | 2012-01-10 |
| PMA | P110031 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 12M-0024 |
| 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 |
|---|---|---|
| P110031 | Original Filing | |
| S024 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S023 | 2018-10-09 | 30-day Notice |
| S022 | 2018-03-01 | Real-time Process |
| S021 | ||
| S020 | 2017-10-11 | Real-time Process |
| S019 | 2017-08-03 | 30-day Notice |
| S018 | 2017-05-24 | 30-day Notice |
| S017 | 2016-12-07 | Real-time Process |
| S016 | 2016-09-07 | Normal 180 Day Track No User Fee |
| S015 | 2016-07-11 | 135 Review Track For 30-day Notice |
| S014 | 2016-02-16 | 30-day Notice |
| S013 | 2016-01-27 | 30-day Notice |
| S012 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S011 | 2015-10-07 | 30-day Notice |
| S010 | 2013-07-19 | Special (immediate Track) |
| S009 | ||
| S008 | 2012-11-30 | 30-day Notice |
| S007 | ||
| S006 | 2012-02-29 | 30-day Notice |
| S005 | 2012-02-02 | 30-day Notice |
| S004 | 2012-02-02 | 30-day Notice |
| S003 | 2012-02-02 | 30-day Notice |
| S002 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S001 | 2012-01-31 | Normal 180 Day Track No User Fee |