OCB — Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection Class III
FDA product code OCB covers "Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OCB
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Unknown
- Implant
- No
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.