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U.S. Department of Health and Human Services

Product Classification
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Device multi-analyte test system with algorithmic analysis for detection of prostate cancer
Definition Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.
Physical State Immunoassay reagents, calibrators, controls, instruments, and software for algorithm.
Technical Method Test system of multiple immunoassays with algorithmic analysis.
Target Area Device utilizes venous blood specimens, but other specimen types may be possible.
Review Panel Immunology
Product CodeQRF
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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