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U.S. Department of Health and Human Services

Product Classification
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Device p2psa
Definition Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Physical State Reagent packs, calibrators, controls, substrate and wash buffer
Technical Method A two-site immunoenzymatic assay using paramagnetic particles coated with a mouse monoclonal anti-[-2]proPSA antibody to capture the [-2]proPSA and mouse monoclonal anti-PSA alkaline phosphatase conjugate that reacts with a chemiluminescent substrate to generate light. Light production is measured with a luminometer.
Target Area peripheral blood
Review Panel Immunology
Product CodeOYA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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