Immunology— FDA advisory panel IM

The immunology panel is the immunoassay wing of the IVD world: tests for autoimmune markers (ANA, rheumatoid factor), allergen-specific IgE systems, complement and immunoglobulin quantitation, tumor-marker assays used for monitoring, and the analyzers those assays run on. The panel sits adjacent to clinical chemistry, microbiology, and hematology, and the boundaries are historical as much as scientific — where a given analyte's product code landed decades ago is where its successors still file.

That inheritance is the main practical reading note: searching for a modern diagnostic by clinical purpose often means checking two or three IVD panels. Tumor markers illustrate the panel's regulatory nuance well — most cleared oncology assays here are indicated for monitoring disease already diagnosed, not for screening, and that distinction between cleared indication and colloquial use is exactly the kind of detail the underlying 510(k) summaries exist to record.