|Trade Name||IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revisions to the product labeling to include a ¿hot zone cutoff¿ under the interpretation of results section. This ¿hot zone cutoff¿ establishes a level at which high hbsag reactive samples may be reported as reactive without confirmatory testing.