FDA product code NQF: Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

NQF is the FDA product code for immunohistochemistry assay, antibody, epidermal growth factor receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under NQF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.

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.

Classification

Recalls for NQF devices

openFDA lists no recalls for product code NQF.

Frequently asked questions

What is FDA product code NQF?

NQF is the FDA product code for immunohistochemistry assay, antibody, epidermal growth factor receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.

What device class is NQF?

Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.

Next steps

• Run an FDA pathway report with predicate devices for product code NQF
• Run a recall and safety report across every NQF manufacturer
• Watch product code NQF for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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