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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,psa,free(non complexed)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
PMA NumberP060005
Date Received02/14/2006
Decision Date05/11/2007
Product Code
MTG[ Registered Establishments with MTG ]
Docket Number 07M-0409
Notice Date 11/09/2007
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the immulite / immulite 1000 and immulite 2000 free psa assay. These devices are indicated for: the immulite / immulite 1000 free psa assay is indicated for in vitro diagnostic use with the immulite / immulite 1000 analyzer for the quantitative measurement of free prostate-specific antigen (psa) not bound to alpha 1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of free psa is used in conjunction with immulite / immulite 1000 total psa to determine a ratio of free psa to total psa (percent free psa). The percent free psa is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with immulite / immulite 1000 total psa values between 4 and 10 ng/ml and digital rectal exam (dre) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer. The immulite 2000 free psa assay is indicated for in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of free prostate-specific antigen (psa) not bound to alpha 1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of free psa is used in conjunction with immulite 2000 total psa to determine a ratio of free psa to total psa (percent free psa). The percent free psa is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with immulite 2000 total psa values between 4 and 10 ng/ml and digital rectal exam (dre) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer.
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S006 S007 S008 
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