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
• Submission Type: PMA
• Regulation Number: 864.1860
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• 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