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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate specific antigen assay (psa)
Regulation Number866.6010
PMA NumberP950021
Supplement NumberS004
Date Received09/20/2001
Decision Date03/19/2002
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product 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 total psa microtiter elisa and is indicated for the following: the oncogene science total psa microtiter elisa is an in vitro diagnostic assay intended to quantitatively measure total psa in human serum. The assay detects psa both as a free molecule, and when complexed by other molecules, principally alpha-1-antichymotrypsin (act). This device is indicated for the measurement of serum psa 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 total psa microtiter elisa is further indicated for follow-up and monitoring of patients with prostate cancer. Psa 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.