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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.
 
DeviceST AIA-PACK PA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080
PMA NumberP910065
Supplement NumberS005
Date Received04/07/2004
Decision Date05/25/2004
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE TOSOH ST AIA-PACK PA ASSAY TO BE USED ON THE TOSOH AIA-360 AND TOSOH AIA-1800 AUTOMATED IMMUNOASSAY SYSTEMS, MEMBERS OF THE TOSOH AIA AUTOMATED IMMUNOASSAY SYSTEM FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME ST AIA-PACK PA AND IS INDICATED FOR: ST AIA-PACK PA IS DESIGNED FOR IN VITRO DIAGNOSTIC USE ONLY FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM ON TOSOH AIA NEX*IA, AIA-600 II, AIA-1800 AND AIA-360 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. THIS 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.
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