Approval for migration of the advia centaur hepatitis b e antigen and the advia centaur hepatitis b e antigen quality control onto the atellica im analyzer. The device, as modified, will be marketed under the trade name atellica im hepatitis b e antigen (hbeag) and atellica im hepatitis b e antigen quality control (hbeag qc) and is indicated for: atellica im hepatitis be antigen (hbeag)the atellica im hepatitis be antigen (hbeag) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of the hepatitis b e antigen (hbeag) in human serum and plasma (potassium edta, lithium heparin, and sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection using the atellica™ im analyzer. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis b virus. Atellica im hepatitis b e antigen quality control (hbeag qc)the atellica® im hepatitis b e antigen quality control (hbeag qc) is for use in monitoring theperformance of the atellica im hbeag assay using the atellica® im analyzer. The performance of the atellica im hbeag quality control material has not been establishedwith any other hbeag assay.
| Device | Atellica IM Hepatitis B e Antigen (HBeAg) |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2017-12-22 |
| Decision Date | 2018-07-12 |
| PMA | P090024 |
| Supplement | S004 |
| Product Code | LOM |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue tarrytown, NY 10591 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P090024 | | Original Filing |
| S011 |
2022-03-22 |
30-day Notice |
| S010 |
2021-04-01 |
30-day Notice |
| S009 |
2020-07-31 |
30-day Notice |
| S008 |
2020-03-09 |
30-day Notice |
| S007 |
2020-02-21 |
30-day Notice |
| S006 |
2019-02-01 |
30-day Notice |
| S005 |
2018-07-19 |
Real-time Process |
| S004 |
2017-12-22 |
Normal 180 Day Track |
| S003 |
2017-03-27 |
30-day Notice |
| S002 |
2015-06-11 |
30-day Notice |
| S001 |
2015-05-05 |
Normal 180 Day Track |
NIH GUDID Devices