Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
OCB · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OCB
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
Y
Implant
N
Third-party review
N
Definition
A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.