Manufacturers of commercial IHC assay reagents, kits, instruments, and computer software are federally regulated with requirements based on risk level classification. In vitro diagnostic use devices (IVD), which include many manufactured products for use in IHC, are under the authority of 21CFR 864.1860.
- Class I: “…provide the pathologist with adjunctive diagnostic information…”“…minimal potential for harm to the user.”
- Class II: “…provide prognostic or predictive data…”“…mandatory performance standards…”
Many antibodies and detection systems are FDA-approved for IVD use. The laboratory must validate the performance (accuracy, precision, sensitivity, and specificity). The extent of validation varies with the FDA status, IVD, or analyte specific reagents (ASRs) and clinical use. Specific validation guidelines apply to predictive markers.