|Trade Name||ABBOTT IMX PSA|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Docket Number|| 97M-0501|
|Supplement Type||panel track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a new intended use and is indicated for the quantitative measurement of prostate specific antigen (psa) in: 1) human serum as an adjunctive test used as an aid in the management of prostate cancer patients; 2) human serum as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostatic biopsy is required for diagnosis of cancer.