Device |
prostrate cancer genes nucleic acid amplification test system |
Definition |
An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes. |
Physical State |
Capture oligonucleotides, magnetic microparticles, transcription-based nucleic acid amplification reagents, chemiluminescent-labeled nucleic acid probes. luminometer, software |
Technical Method |
Utilizes nucleic acid probes and/or primers along with other reagents to detect prostrate cancer genes RNA from human specimens. |
Target Area |
Currently this type of device is only utilized on urine specimens, but other specimen types may be possible. |
Review Panel |
Immunology |
Product Code | OYM |
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 |