Approval of the adiva centaur anti-hbe2 (ahbe2) assay. The qualitative detection of antibodies to the e antigen of the hepatitis b virus (hbv) in human pediatric (2–21 years old) and adult serum, edta plasma, or lithium heparin plasma using the advia centaur systems (xp/xpt/cp). Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis b virus (hbv) infection in patients with signs or symptoms of hepatitis b infection, or with risk factors for hbv infection, or with known hbv infection. Results of the assay, in conjunction with other diagnostic information, may be used to aid in determining hbv seroconversion.
| Device | ADVIA Centaur Anti-HBe2 (aHBe2) assay |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Date Received | 2020-03-09 |
| Decision Date | 2021-07-14 |
| PMA | P200017 |
| Supplement | S |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200017 | | Original Filing |
| S002 |
2022-03-22 |
30-day Notice |
| S001 |
2021-08-10 |
Normal 180 Day Track |
NIH GUDID Devices