Approval for the elecsys anti-hbc immunoassay & elecsys precicontrol anti-hbc for use on the modular analytics e170 immunoassay analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium-heparin, sodium-citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. Further hbv serological marker testing is required to define the specific disease state. The elecsys anti-hbc immunoassay's performance has not been established for the monitoring hbv disease or therapy. The electro- chemiluminescence immunoassay "eclia" is intended for use on the modular analytics ei70 immunoassay analyzer. The elecsys preci-control anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the modular analytics e170 immunoassay analyzer.
| Device | ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC |
| 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 | 2010-07-30 |
| Decision Date | 2011-06-22 |
| Notice Date | 2011-07-01 |
| PMA | P100031 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 11M-0502 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 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 |
|---|
| P100031 | | Original Filing |
| S027 |
2021-09-30 |
Normal 180 Day Track |
| S026 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S025 |
2018-10-09 |
30-day Notice |
| S024 |
2018-04-17 |
Real-time Process |
| S023 |
2018-03-01 |
Real-time Process |
| S022 | | |
| S021 |
2017-10-11 |
Real-time Process |
| S020 |
2017-09-28 |
Normal 180 Day Track |
| S019 |
2017-08-03 |
30-day Notice |
| S018 |
2017-05-24 |
30-day Notice |
| S017 |
2017-02-21 |
Normal 180 Day Track |
| S016 |
2016-02-16 |
30-day Notice |
| S015 |
2016-01-27 |
30-day Notice |
| S014 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S013 |
2015-10-07 |
30-day Notice |
| S012 |
2014-10-16 |
Real-time Process |
| S011 |
2014-04-04 |
Real-time Process |
| S010 |
2012-11-30 |
30-day Notice |
| S009 |
2012-09-04 |
Normal 180 Day Track |
| S008 |
2012-09-04 |
Normal 180 Day Track |
| S007 | | |
| S006 |
2012-02-29 |
30-day Notice |
| S005 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S004 |
2011-08-29 |
135 Review Track For 30-day Notice |
| S003 |
2011-08-17 |
Normal 180 Day Track No User Fee |
| S002 |
2011-08-17 |
135 Review Track For 30-day Notice |
| S001 |
2011-07-01 |
30-day Notice |
NIH GUDID Devices