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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 NameST AIA-PACK PA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameimmunoassay, psa
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
PMA NumberP910065
Supplement NumberS001
Date Received03/25/1999
Decision Date09/10/1999
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 00M-1523
Notice Date 09/21/2000
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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