Premarket Approval (PMA)

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 Name: ABBOTT AXSYM TOTAL PSA ASSAY
• Classification Name: analyzer, chemistry (photometric, discrete), for clinical use
• Generic Name: immunochemistry analyzer
• Regulation Number: 862.2160
• Applicant: ABBOTT LABORATORIES
• PMA Number: P910007
• Supplement Number: S011
• Date Received: 07/29/2004
• Decision Date: 09/27/2004
• Product Code: JJE [ Registered Establishments with JJE ]
• Advisory Committee: Immunology
• Supplement Type: real-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.