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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 NameABBOTT ARCHITECT TOTAL PSA ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameimmunochemistry analyzer
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS010
Date Received04/01/2004
Decision Date04/28/2004
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the abbott architect total psa assay to be used on the architect i2000sr platform, a member of the architect i2000 instrument family. The device, as modified, will be marketed under the same trade name architect total psa assay and is indicated: the architect total psa assay is a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of total psa (both free psa and psa complexed to alpha-1-antichymotrypsin [psa-act]) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostatic biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.
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