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.
| Device | Elecsys Anti-HBc II |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-04-04 |
| PMA | P100032 |
| Supplement | S021 |
| 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 Rd. indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Modification Of The Assay Reagents To Improve The Tolerance To Biotin Interference, Updating The Sample Stability Claims, And Revisions To The Device Labeling. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100032 | Original Filing | |
| S021 | 2021-09-30 | Normal 180 Day Track |
| S020 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S019 | 2018-10-09 | 30-day Notice |
| S018 | 2018-03-01 | Real-time Process |
| S017 | 2017-10-11 | Real-time Process |
| S016 | 2017-08-03 | 30-day Notice |
| S015 | 2017-05-24 | 30-day Notice |
| S014 | 2017-02-21 | Normal 180 Day Track |
| S013 | 2016-02-16 | 30-day Notice |
| S012 | 2016-01-27 | 30-day Notice |
| S011 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S010 | 2015-10-07 | 30-day Notice |
| S009 | 2013-04-09 | Real-time Process |
| S008 | 2012-11-30 | 30-day Notice |
| S007 | 2012-09-04 | Normal 180 Day Track |
| 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 |