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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
6000 shoreline court
suite 101
south san francisco, CA 94080
PMA NumberP910065
Supplement NumberS001
Date Received03/25/1999
Decision Date09/10/1999
Product Code LTJ 
Docket Number 00M-1523
Notice Date 09/21/2000
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers. This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness