NQF · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860
Classification
FDA Product Code
NQF
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 864.1860
Review panel
PA
Medical specialty
Hematology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.