Approval for change in quality controls that add a new specification, or otherwise provide additional assurance of purity, identity, strength, or reliability of the elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs.
| Device | ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS |
| 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 | 2005-09-15 |
| Decision Date | 2005-10-06 |
| PMA | P010054 |
| Supplement | S002 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate 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 |
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