FDA 510K for Control Material - HER-2/NEU Immunohistochemistry
The HER-2/neu immunohistochemistry system, particularly the Roche HER2 (4B5) clone, is crucial for assessing HER2 status in tumours. This system utilizes FDA-approved in vitro diagnostic (IVD) tests to evaluate HER2 protein expression, which is vital for informing treatment choices for patients, especially in cases of hormone receptor-negative tumours that show HER-2 amplification and overexpression. For instance, the HercepTest is well-known for its high sensitivity in detecting HER2 expression, particularly in tumours with gene amplification.
Intended Use of Control Material HER-2/NEW, Immunohistochemistry
It is intended for laboratory use to control semi-quantitative immunohistochemistry using different Her2/neu antibodies. This control ensures that the performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Control Material – HER-2/NEU Immunohistochemistry
Control Material HER-2/NEU Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | NJW | Control Material, Her-2/Neu, Immunohistochemistry | Immunohistochemistry reagents and kits | 864.1860 | 2 |
| – | – | – | |||
| – | – | – |
Device Description for Control Material, Her-2/Neu, Immunohistochemistry
This product provides appropriate control for semi-quantitative immunohistochemistry using polyclonal or monoclonal HER2/neu antibodies. Each slide contains four control sections prepared for breast cancer cell lines that represent different levels of Her-2heu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, and the slide is positively charged. It is a prescription-use device.
Performance Testing (Analytical)
- Precision/Reproducibility
- Detection studies
- Detection limit
- Analytical specificity
- Traceability (controls, calibrators, or method)
- Retrospective Study
- Analytical Sensitivity
- Assay cut-off.
- Analytical Specificity (Cross Reactivity)
- Interfering Substances
- Precision – Intra and Inter-assay
- Prozone effect study
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Required for 510k and IVDR CE Marking submission.