|Trade Name||ABBOTT ARCHITECT TOTAL PSA ASSAY|
|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||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the abbott architect total psa assay to be used on the architect i2000sr platform, a member of the architect i2000 instrument family. The device, as modified, will be marketed under the same trade name architect total psa assay and is indicated: the architect total psa assay is a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of total psa (both free psa and psa complexed to alpha-1-antichymotrypsin [psa-act]) in human serum: 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. Prostatic biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.