Product code NQF

Device name

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

Medical specialty

Hematology

Device class

3

Regulation number

864.1860

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset