Approval for claims to test neonate and pediatric populations with the fda approved advia centaur hbc total readypack reagents and advia centaur hbc total quality control materials. The device, as modified, will be marketed under the trade name advia centaur hbc total readypack reagents and advia centaur hbc total quality control materials and is indicated for:advia centaur and advia centaur xp systemsthe advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human neonatal, pediatric and adult serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur and advia centaur xp systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur cp system:the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human neonatal, pediatric, and adult serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur cp system. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. For additional information please refer to the approval order.
| Device | ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL |
| 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 | 2014-09-09 |
| Decision Date | 2015-02-27 |
| PMA | P040004 |
| Supplement | S010 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040004 | | Original Filing |
| S021 |
2022-03-22 |
30-day Notice |
| S020 |
2021-04-01 |
30-day Notice |
| S019 |
2020-12-22 |
Real-time Process |
| S018 |
2020-07-31 |
30-day Notice |
| S017 |
2020-03-09 |
30-day Notice |
| S016 |
2020-02-21 |
30-day Notice |
| S015 |
2019-02-01 |
30-day Notice |
| S014 |
2018-07-19 |
Real-time Process |
| S013 |
2017-07-17 |
Normal 180 Day Track |
| S012 |
2015-07-13 |
Normal 180 Day Track |
| S011 |
2015-06-11 |
30-day Notice |
| S010 |
2014-09-09 |
Normal 180 Day Track |
| S009 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S008 |
2012-01-09 |
30-day Notice |
| S007 |
2010-01-08 |
30-day Notice |
| S006 |
2009-05-18 |
Normal 180 Day Track |
| S005 |
2009-03-31 |
Normal 180 Day Track |
| S004 |
2009-03-09 |
Normal 180 Day Track No User Fee |
| S003 |
2009-02-04 |
30-day Notice |
| S002 |
2008-08-26 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices