P2psa
Basic Information
- Device Name
- P2psa
- Trade Name
- ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
- PMA Number
- P090026
- Device Class
- FDA Class 3
- Product Code
- OYA
- Generic Name
- P2psa
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 14, 2012
- Date Received
- November 17, 2009
- Expedited Review
- N
- Docket Number
- 12M-0638
Advisory Committee 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 FREEPSA, 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 ASAN 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYA | P2psa | FDA class 3 | Unknown |