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 1) the inclusion of a second antigen source for the recombinant hepatitis b core antigen used in reagent 1 of the test kit; 2) an update in the device by changing the standardization traceability to the world health organization standard nibsc 95/522; 3) extension of the reagent rackpack onboard stability from 4 weeks to 8 weeks; 4) addition of k3-edta plasma as a specimen type; and 5) modification of the device name.
| Device | Elecsys Anti-HBC Immunoassay test system |
| 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 | 2017-02-21 |
| Decision Date | 2017-08-16 |
| PMA | P100032 |
| Supplement | S014 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| 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 |