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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 NumberS005
Date Received04/07/2004
Decision Date05/25/2004
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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