|Trade Name||COMPLEXED PSA MICROTITER ELISA|
|Classification Name||antigen(complexed),prostate specific,(cpsa)|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name oncogene science complexed psa microtiter elisa and is indicated for the following: the oncogene science complexed psa microtiter elisa is an in vitro diagnostic assay intended to quantitatively measure complexed psa (cpsa) in human serum. This device is indicated for the measurement of serum cpsa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The oncogene science complexed psa microtiter elisa is further indicated for follow-up and monitoring of patients with prostate cancer. Cpsa levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.