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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 NameACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Namep2psa
ApplicantBECKMAN COULTER, INC.
PMA NumberP090026
Date Received11/17/2009
Decision Date06/14/2012
Product Code
OYA
Docket Number 12M-0638
Notice Date 06/20/2012
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 access hybritech p2psa on the access immunoassay systems. This device is indicated for: the access hybritech p2psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]propsa antigen, an isoform of free psa, in human serum using the access immunoassay systems. Access hybritech p2psa is intended to be used in combination with access hybritech (total) psa and access hybritech free psa to calculate the beckman coulter prostate health index (phi), an in vitro diagnostic multivariate index assay (ivdmia). Beckman coulter phi as calculated using the access hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total psa >= 4. 0 to <= 10. 0 ng/ml, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsyis required for diagnosis of cancer.
Approval Order Approval Order
Supplements: S001 S004 S005 S006 S007 S008 S009 S010 S011 
S013 
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