|Trade Name||ABBOTT ARCHITECT TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the abbott architect total psa assay. The architect total psa assay is indicated: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.