Approval for immulite/ immulite 1000 andimmulite 2000 anti hbs assay. The device is indicated for:immulite/ immulite 1000for in vitro diagnostic use with the immulite or immulite 1000 analyzers for thequalitative and quantitative measurement of total antibodies to the hepatitis b surface antigen(anti-hbs) in human serum and plasma (heparinized). Assay results may be used as an aid in thedetermination of susceptibility to hepatitis b virus (hbv) infection for 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 withhbv infection. A reactive assay result will allow a differential diagnosis in individualsdisplaying signs and symptoms of hepatitis in whom etiology is unknown. Immulite 2000for in vitro diagnostic use with the immulite 2000 systems automated immunoassayanalyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis bsurface antigen (anti-hbs) in human serum and plasma (heparinized). Assay results may be usedas an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following i-ibv 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 differentialdiagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology isunknown.
| Device | IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS |
| 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 | 2008-02-25 |
| Decision Date | 2009-12-16 |
| PMA | P010052 |
| Supplement | S004 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|
| P010052 | | Original Filing |
| S016 |
2022-09-15 |
30-day Notice |
| S015 | | |
| S014 |
2020-08-12 |
30-day Notice |
| S013 |
2019-11-25 |
30-day Notice |
| S012 |
2014-11-28 |
135 Review Track For 30-day Notice |
| S011 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S010 |
2011-08-16 |
30-day Notice |
| S009 |
2011-08-08 |
30-day Notice |
| S008 |
2011-02-18 |
Real-time Process |
| S007 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S006 | | |
| S005 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S004 |
2008-02-25 |
Normal 180 Day Track |
| S003 |
2005-08-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices