| 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. |
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| Trade Name | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS |
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| Classification Name | p2psa |
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| Applicant | BECKMAN COULTER, INC. |
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| PMA Number | P090026 |
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| Date Received | 11/17/2009 |
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| Decision Date | 06/14/2012 |
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| Product Code | |
| Docket Number | 12M-0638 |
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| Notice Date | 06/20/2012 |
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| Advisory Committee |
Immunology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Supplements: |
S001 S004 S005 |
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