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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 AXSYM TOTAL PSA ASSAY
Classification Nameanalyzer, chemistry (photometric, discrete), for clinical use
Generic Nameimmunochemistry analyzer
Regulation Number862.2160
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS011
Date Received07/29/2004
Decision Date09/27/2004
Product Code
JJE[ Registered Establishments with JJE ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the following modifications to the abbott axsym total psa assay: 1) change the functional sensitivity claim to 0. 06 ng/ml 2) addition of flomax to the analytical specificity section of the package insert 3) minor labeling changes to the package insert for the purpose of clarification, updates and conformation to requirements of the european community directives. The axsym total psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of total psa (both free psa and psa complexed to alpha-1-antichymotrypsin) 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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