Premarket Approval (PMA)

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.

• Device: ST AIA-PACK PA
• Generic Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Regulation Number: 866.6010
• Applicant: TOSOH BIOSCIENCE, INC.; 6000 SHORELINE COURT; SUITE 101; SOUTH SAN FRANCISCO, CA 94080
• PMA Number: P910065
• Supplement Number: S001
• Date Received: 03/25/1999
• Decision Date: 09/10/1999
• Product Code: LTJ
• Docket Number: 00M-1523
• Notice Date: 09/21/2000
• Advisory Committee: Immunology
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling