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 Code | QRF |
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 |