Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
QRF · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QRF
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
IM
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.