FDA 510(k) Immunology Devices

FDA 510(k) Immunology Devices - Regulatory Overview

FDA 510(k) immunology devices include diagnostic systems that detect immune responses, antibodies and antigens. The FDA review panel code is IM.

Key categories:

• Immunoassay analyzers - automated platforms for ELISA, CLIA and lateral flow
• Allergy testing systems - specific IgE measurement and skin prick test devices
• Autoimmune diagnostics - ANA, anti-dsDNA, rheumatoid factor assays
• Transplant diagnostics - HLA typing and crossmatch systems

Most devices are Class II under 21 CFR Part 866. Data sourced from FDA 510(k) public files. Updated monthly.