Approval for the elecsys hbsag ii, elecsys hbsag confirmatory test, and precicontrol hbsag ii. This device is indicated for:elecsys hbsag ii immunoassay for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human adult and pediatric (2 to 21 years of age) serum and plasma (sodium heparin, lithium heparin, k2 edta, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals at risk for infection with hbv or with signs and symptoms of hepatitis. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates at high risk of acquiring hbv during the perinatal period. The electrochemiluminescence immunoassay “eclia” is intended for use on the cobas e 601 immunoassay analyzer. Elecsys hbsag confirmatory testfor elecsys hbsag confirmatory test used with elecsys hbsag immunoassay:immunoassay for in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (sodium heparin, k3 edta, sodium citrate) samples repeatedly reactive when tested with the elecsys hbsag immunoassay. This assay is intended for use on the elecsys and cobas e immunoassay analyzers. For elecsys hbsag confirmatory test used with elecsys hbsag ii: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 elecsys hbsag ii. This assay is intended for use on the cobas e 601 immunoassay analyzer. Precicontrol hbsag iiprecicontrol hbsag ii is used for quality control of the elecsys hbsag ii immunoassay on the cobas e 601 immunoassay analyzer. The performance of precicontrol hbsag ii has not been established with any other hbsag assay.
| Device | Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II |
| 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, INC. |
| Date Received | 2016-07-01 |
| Decision Date | 2016-12-23 |
| Notice Date | 2017-01-18 |
| PMA | P160019 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 16M-4530 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS, INC. 9115 Hague Road indianapolis, IN 46038 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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