OCB

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Product code

OCB

Device name

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

Flag

Life-sustaining / life-supporting

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).