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 k3-edta plasma as a specimen type for the elecsys anti-hbc igm immunoassay for use on the cobas e 411, cobas e 601, cobas e 602, and modular analytics e170 analyzers.
| Device | MODULAR ANALYSTICS E170 |
| 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 | 2016-12-07 |
| Decision Date | 2017-02-28 |
| PMA | P110025 |
| Supplement | S018 |
| Product Code | LOM |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
|---|---|---|
| P110025 | Original Filing | |
| S023 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S022 | 2018-10-09 | 30-day Notice |
| S021 | 2017-10-11 | Real-time Process |
| S020 | 2017-08-03 | 30-day Notice |
| S019 | 2017-05-24 | 30-day Notice |
| S018 | 2016-12-07 | Real-time Process |
| S017 | 2016-09-07 | Normal 180 Day Track No User Fee |
| S016 | 2016-07-11 | 135 Review Track For 30-day Notice |
| S015 | 2016-02-16 | 30-day Notice |
| S014 | 2016-01-27 | 30-day Notice |
| S013 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S012 | 2015-10-07 | 30-day Notice |
| S011 | 2014-10-16 | Real-time Process |
| 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 |