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 anti-hbc igm assay. The device, as modified, will be marketed under the trade name immulite 2000 xpi anti-hbc igm assay and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b virus infections in conjunction with other serological and clinical information.
| Device | ANTI-HBC IGM |
| 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 | P010053 |
| Supplement | S007 |
| 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 |
|---|
| P010053 | | Original Filing |
| S016 |
2022-09-15 |
30-day Notice |
| S015 | | |
| S014 |
2022-02-28 |
30-day Notice |
| S013 |
2020-12-22 |
Real-time Process |
| S012 |
2020-08-12 |
30-day Notice |
| S011 |
2019-11-25 |
30-day Notice |
| S010 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S009 |
2011-08-16 |
30-day Notice |
| S008 |
2011-08-08 |
30-day Notice |
| S007 |
2011-02-18 |
Real-time Process |
| S006 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S003 |
2005-08-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices