Product Classification

• Device: immunohistochemistry assay, antibody, epidermal growth factor receptor
• Regulation Description: Immunohistochemistry reagents and kits.
• 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.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Product Code: NQF
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: PMA
• Regulation Number: 864.1860
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-219 CLSI I/LA28-A2
  Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.

Third Party Review

Not Third Party Eligible