FDA product code OCB: Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
OCB is the FDA product code for rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection. It is a Class III device, reviewed by the Immunology panel. Devices under OCB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for OCB devices
openFDA lists no recalls for product code OCB.
Frequently asked questions
What is FDA product code OCB?
OCB is the FDA product code for rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection. It is a Class III device, reviewed by the Immunology panel.
What device class is OCB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OCB
- Run a recall and safety report across every OCB manufacturer
- Watch product code OCB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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