Approval for the ad via centaur anti-hbs2 (ahbs2) master curvematerial. The device, as modified, will be marketed under the trade name ad via centaur antihbs2(ahbs2) assay, advia centaur anti-hbs2 (ahbs2) quality control material, andadvia centaur anti-hbs2 (ahbs2) master curve material and is indicated for:advia centaur anti-hbs2 (ahbs2) assay: the advia centaur anti-hbs2 assay is an in vitro diagnostic immunoassay for the qualitativeand quantitative detennination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma (edta, lithium-heparinized, or sodium-heparinized)and neonatal samples using the advia centaur and advia centaur xp systems. The assayresults may be used as an aid in the detennination 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 adifferential 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 adviacentaur systems. The performance of the anti-hbs2 quality control material has not been established with any other anti-hbs assays. Advia centaur anti-hbs2 (ahbs2) master curve material: the advia centaur anti-hbs2 (ahbs2) master curve material (mcm) is for in vitro use in the verification of calibration and reportable range of the ad via centaur ahbs2 assay.
| Device | ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS |
| 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 | 2012-09-28 |
| Decision Date | 2013-09-26 |
| PMA | P100039 |
| Supplement | S002 |
| 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 | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591 |
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