|Trade Name||AXSYM TOTAL PSA & ARCHITECT TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Supplement Type||special (immediate track)|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for addition of a bsa screening test to identify protease contamination in vendor lots of incoming bsa prior to purchase.