NQF
- Product code
- NQF
- Device name
- Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
- Device class
- Class 3
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- PMA
FDA classification definition
The epidermal growth factor receptor (EGFR) antibody/assay is a qualitative immunohistochemical antibody/assay to identify EGFR expression in normal and neoplastic tissues routinely-fixed for histological evaluation. EGFR antibody/assay specifically detects the EGFR (HER1) protein in EGFR-expressing cells. This antibody/assay is indicated as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab, a monoclonal antibody drug. This will be a specialized subcategory for EGFR immunohistochemistry assays under the general heading of the regulation for all Immunohistochemistry assays.
Official FDA classification page: NQF
Classification and pathway per current FDA publications. Data from openFDA (CC0).