Approval for the elecsys hbeag immunoassay and elecsys precicontrol hbeag. This device is indicated for:elecsys hbeag immunoassaythe elecsys hbeag immunoassay is intended for the in vitro qualitative determination of hepatitis b e antigen (hbeag) in human serum or plasma (k2-edta, lithium or sodium heparin, and sodium citrate) in adult patients with symptoms of hepatitis or at risk for hepatitis b virus (hbv) infection. The 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 or recovery from hepatitis b infection. The electrochemilumin-escence immunoassay eclia is intended for use on the modular analytics e170 analyzer. Elecsys precicontrol hbeag elecsys precicontrol hbeag is used for quality control of the elecsys hbeag immunoassay on the modular analytics e170 analyzer.
| Device | ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG |
| 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 OPERATIONS INC |
| Date Received | 2013-05-30 |
| Decision Date | 2014-03-14 |
| Notice Date | 2014-03-31 |
| PMA | P130015 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 14M-0326 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Rd indianapolis, IN 46250 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130015 | | Original Filing |
| S016 |
2018-10-09 |
30-day Notice |
| S015 |
2018-04-17 |
Real-time Process |
| S014 |
2017-10-11 |
Real-time Process |
| S013 |
2017-09-15 |
Normal 180 Day Track |
| S012 |
2017-08-03 |
30-day Notice |
| S011 |
2017-07-18 |
30-day Notice |
| S010 |
2017-05-24 |
30-day Notice |
| S009 |
2016-12-20 |
Normal 180 Day Track No User Fee |
| S008 |
2016-10-26 |
30-day Notice |
| S007 |
2016-04-28 |
Normal 180 Day Track |
| S006 |
2016-02-16 |
30-day Notice |
| S005 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S004 |
2015-10-07 |
30-day Notice |
| S003 |
2015-06-29 |
30-day Notice |
| S002 |
2014-10-16 |
Real-time Process |
| S001 |
2014-05-23 |
30-day Notice |
NIH GUDID Devices