Approval for (1) the inclusion of a biotin scavenger antibody in reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for elecsys hbsag ii and elecsys hbsag confirmatory test.
| Device | Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS, INC. |
| Date Received | 2019-09-03 |
| Decision Date | 2020-02-27 |
| PMA | P160019 |
| Supplement | S010 |
| 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, 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