Approval to extend application of the elecsys hbsag and elecsys anti-hbs test systems onto the updated version of the modular analytics e170 analyzer known as the cobas e 601 analyzer. While the modular analytics modular system integrates the e170 module with clinical chemistry modules p or d, the cobas e 601 immunoassay analyzer is a component of the c6000 modular system which integrates immunology testing with the cobas c 501 clinical chemistry analyser. There have been no changes to the composition of any of te test system reagents (immunoassay, controls or confirmatory test), the application parameters, the analyzer¿s analytical measuring component or how the results are calculated. The indications for use of the two test systems remain the same.
| Device | ELECSYS ANTI-HBS 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 | 2008-04-30 |
| Decision Date | 2008-10-30 |
| PMA | P010054 |
| Supplement | S008 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010054 | | Original Filing |
| S042 |
2021-12-02 |
30-day Notice |
| S041 |
2021-11-29 |
30-day Notice |
| S040 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S039 |
2018-10-09 |
30-day Notice |
| S038 |
2018-09-04 |
Normal 180 Day Track |
| S037 |
2018-04-27 |
Real-time Process |
| S036 |
2018-04-17 |
Real-time Process |
| S035 |
2018-03-01 |
Real-time Process |
| S034 |
2018-02-01 |
Normal 180 Day Track No User Fee |
| S033 | | |
| S032 |
2017-10-11 |
Real-time Process |
| S031 |
2017-08-03 |
30-day Notice |
| S030 |
2017-05-24 |
30-day Notice |
| S029 |
2016-10-26 |
30-day Notice |
| S028 |
2016-02-16 |
30-day Notice |
| S027 |
2016-01-27 |
30-day Notice |
| S026 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S025 |
2015-10-07 |
30-day Notice |
| S024 |
2014-11-25 |
30-day Notice |
| S023 |
2014-04-04 |
Real-time Process |
| S022 |
2013-04-09 |
Real-time Process |
| S021 |
2012-11-30 |
30-day Notice |
| S020 | | |
| S019 |
2012-02-29 |
30-day Notice |
| S018 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S017 |
2011-10-11 |
Normal 180 Day Track |
| S016 |
2011-08-29 |
135 Review Track For 30-day Notice |
| S015 |
2011-07-12 |
30-day Notice |
| S014 |
2011-05-17 |
Normal 180 Day Track No User Fee |
| S013 |
2011-04-11 |
30-day Notice |
| S012 |
2010-05-27 |
30-day Notice |
| S011 |
2009-12-22 |
Real-time Process |
| S010 |
2008-09-02 |
30-day Notice |
| S009 |
2008-06-09 |
Real-time Process |
| S008 |
2008-04-30 |
Normal 180 Day Track |
| S007 |
2007-09-04 |
Normal 180 Day Track |
| S006 | | |
| S005 |
2006-07-11 |
Special (immediate Track) |
| S004 |
2006-06-13 |
Real-time Process |
| S003 |
2005-10-28 |
Real-time Process |
| S002 |
2005-09-15 |
Special (immediate Track) |
| S001 |
2004-12-22 |
Normal 180 Day Track |
NIH GUDID Devices