FDA Product Code DFH: Kappa, Antigen, Antiserum, Control
Under FDA product code DFH, kappa antigen antisera and controls are cleared for use in immunophenotyping of lymphoproliferative disorders.
These reagents detect kappa light chain expression on B lymphocytes and plasma cells by immunohistochemistry or flow cytometry. Assessment of kappa/lambda light chain ratio is used to identify monoclonal immunoglobulin production in multiple myeloma and B-cell lymphomas.
DFH devices are Class II medical devices, regulated under 21 CFR 866.5550 and reviewed by the FDA Immunology panel.
Leading manufacturers include Sebia, The Binding Site, Ltd. and The Binding Site Group , Ltd..
FDA 510(k) Cleared Kappa, Antigen, Antiserum, Control Devices (Product Code DFH)
About Product Code DFH - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code DFH since 1978, with 63 receiving FDA clearance (average review time: 148 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under DFH have taken an average of 84 days to reach a decision - down from 150 days historically, suggesting improved FDA processing for this classification.
DFH devices are reviewed by the Immunology panel. Browse all Immunology devices →