Approval for the addition of a new instrument platform, and changing the assay from a qualitative assay to a quantitative assay. The device, as modified, will be marketed under the trade name elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs and is indicated: elecsys anti-hbs immunoassay -for the in vitro quantitative determination of total antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma (edta). The electrochemiluminescence immunoassay? Eclia? Is intended for use on the roche elecsys 2010 and modular analytics e170 (elecsys module) immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results maybe used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection. Elecsys precicontrol anti-hbs - for the quality control of the elecsys anti-hbs immunoassay on the elecsys 2010 and modular analytics e170 immunoassay analyzers. The performance of elecsys precicontrol anti-hbs has not been established with any other anti-hbs assay.
| Device | ELECSYS ANTI-HBS IMMUNOASSAY AND 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 | 2004-12-22 |
| Decision Date | 2007-03-13 |
| PMA | P010054 |
| Supplement | S001 |
| 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