Approval for introduction of a new instrument model, the immulite 2000 xpi analyzer, as a new family member of the currently approved immulite 2000 analyzer, to be used with the currently approved immulite 2000 hbsag assay. The device, as modified, will be marketed under the trade name immulite 2000 hbsag assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information.
| Device | HBSAG |
| 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 Products, LTD |
| Date Received | 2011-02-18 |
| Decision Date | 2011-05-12 |
| PMA | P010050 |
| Supplement | S012 |
| Product Code | LOM |
| 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 Products, LTD glyn Rhonwy llanberis, Caernarfon LL55 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010050 | | Original Filing |
| S021 |
2022-09-15 |
30-day Notice |
| S020 | | |
| S019 |
2021-05-12 |
30-day Notice |
| S018 |
2020-08-12 |
30-day Notice |
| S017 |
2019-11-25 |
30-day Notice |
| S016 |
2014-07-02 |
135 Review Track For 30-day Notice |
| S015 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S014 |
2011-08-16 |
30-day Notice |
| S013 |
2011-08-08 |
30-day Notice |
| S012 |
2011-02-18 |
Real-time Process |
| S011 |
2010-09-29 |
Normal 180 Day Track |
| S010 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2009-05-13 |
Real-time Process |
| S007 |
2008-12-02 |
Normal 180 Day Track |
| S006 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S005 |
2006-08-04 |
30-day Notice |
| S004 | | |
| S003 |
2003-05-22 |
30-day Notice |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices