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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 NameACCESS HYBRITECH PSA WHO STANDARDIZATION
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namekit, test, prostate specific antigen
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS021
Date Received04/09/2007
Decision Date05/09/2008
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 08M-0425
Notice Date 07/25/2008
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the access hybritech psa reagents on the access immunoassay systems. The access hybritech psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (psa) in human serum using the access immunoassay systems. The 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 in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of psa to aid in the prognosis and management of patients with prostate cancer.
Approval Order Approval Order
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