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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.
 
Trade NameCOMPLEXED PSA MICROTITER ELISA
Classification Nameantigen(complexed),prostate specific,(cpsa)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP990055
Supplement NumberS002
Date Received09/20/2001
Decision Date03/19/2002
Product Code
NAF[ Registered Establishments with NAF ]
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 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.
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