# Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQF)
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