(1) for the elecsys hbsag ii auto confirm:immunoassay for in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (sodium heparin, lithium heparin, k2-edta, sodium citrate) samples repeatedly reactive when tested with the elecsys hbsag ii assay. The electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers. (2) for the precicontrol hbsag auto confirm:precicontrol hbsag auto confirm is used for quality control of the elecsys hbsag ii auto confirm immunoassay on the cobas e 801 immunoassay analyzer. (3) for the precicontrol hbsag ii:precicontrol hbsag ii is used for quality control of the elecsys hbsag ii and elecsys hbsag ii auto confirm immunoassays on the cobas e immunoassay analyzers. The performance of precicontrol hbsag ii has not been established with any other hbsag assay.
| Device | Elecsys HBsAg II Auto Confirm |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS, INC. |
| Date Received | 2019-11-27 |
| Decision Date | 2020-10-19 |
| PMA | P160019 |
| Supplement | S011 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS, INC. 9115 Hague Road indianapolis, IN 46038 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160019 | | Original Filing |
| S013 |
2021-11-29 |
30-day Notice |
| S012 |
2021-08-02 |
Normal 180 Day Track |
| S011 |
2019-11-27 |
Normal 180 Day Track |
| S010 |
2019-09-03 |
Normal 180 Day Track |
| S009 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S008 |
2018-10-09 |
30-day Notice |
| S007 |
2018-04-17 |
Real-time Process |
| S006 |
2017-10-11 |
Real-time Process |
| S005 |
2017-08-03 |
30-day Notice |
| S004 |
2017-07-28 |
Normal 180 Day Track |
| S003 |
2017-07-28 |
Normal 180 Day Track |
| S002 |
2017-05-24 |
30-day Notice |
| S001 |
2017-05-09 |
Normal 180 Day Track |
NIH GUDID Devices