Approval for advia centaur anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur and advia centaur xp systems. This device is indicated for: advia centaur anti-hbs2 (ahbs2) assay, the advia centaur anti-hb2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum of plasma (edta, lithium-heparinized, or sodium-heparinized) and neonatal samples using the advia centaur and advia centaur xp systems. The assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been fda-cleared or approved for the screening of blood or plasma donors. Advia centaur anti-hbs2 (ahbs2) quality control material, for in vitro diagnostic use in monitoring the performance of the anti-hbs2 assay on the advia centaur systems. The performance of the anti-hbs2 quality control material has not been established with any other anti-hbs assays.
| Device | ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL |
| 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 INC. |
| Date Received | 2010-08-17 |
| Decision Date | 2012-01-20 |
| Notice Date | 2012-01-24 |
| PMA | P100039 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 12M-0075 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100039 | | Original Filing |
| S015 |
2022-03-22 |
30-day Notice |
| S014 |
2022-01-20 |
30-day Notice |
| S013 |
2021-04-01 |
30-day Notice |
| S012 |
2021-03-26 |
30-day Notice |
| S011 |
2020-12-22 |
Real-time Process |
| S010 |
2020-07-31 |
30-day Notice |
| S009 |
2020-03-09 |
30-day Notice |
| S008 |
2020-02-21 |
30-day Notice |
| S007 |
2019-02-01 |
30-day Notice |
| S006 |
2018-07-19 |
Real-time Process |
| S005 |
2017-07-14 |
Normal 180 Day Track |
| S004 |
2015-07-13 |
Normal 180 Day Track |
| S003 |
2015-06-11 |
30-day Notice |
| S002 |
2012-09-28 |
Real-time Process |
| S001 |
2012-04-30 |
Normal 180 Day Track |
NIH GUDID Devices