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 Siemens Healthcare Diagnostics Products GmbH, Diazyme Laboratories, Inc. and Beckman Instruments, Inc..
63
Total
63
Cleared
148d
Avg days
1978
Since
Declining activity -
2 submissions in the last 2 years
vs 5 in the prior period
Review times improving: avg
84d
recently vs 150d historically
FDA 510(k) Cleared Kappa, Antigen, Antiserum, Control Devices (Product Code DFH)
63 devices
Cleared
Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
Diazyme Laboratories, Inc.
Immunology
80d
Cleared
May 23, 2025
Optilite® Freelite Mx Kappa Free Kit
The Binding Site Group , Ltd.
Immunology
87d
Cleared
Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
Sebia
Immunology
267d
Cleared
Jan 24, 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
The Binding Site, Ltd.
Immunology
265d
Cleared
Nov 18, 2022
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Sebia
Immunology
626d
Cleared
Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
Immunology
468d
Cleared
Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories, Inc.
Immunology
212d
Cleared
Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH
Immunology
212d
Cleared
Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH
Immunology
511d
Cleared
Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH
Immunology
621d
Cleared
May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Products GmbH
Immunology
29d
Cleared
Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
Siemens Healthcare Diagnostics Products GmbH
Immunology
90d
Cleared
Aug 23, 2018
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
The Binding Site Group , Ltd.
Immunology
260d
Cleared
Jun 26, 2018
Diazyme Human Kappa Free Light Chain Assay
Diazyme Laboratories, Inc.
Immunology
25d
Cleared
Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
Beckman Instruments, Inc.
Immunology
108d
Cleared
Jun 21, 1990
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
Beckman Instruments, Inc.
Immunology
16d
Cleared
Dec 06, 1988
BECKMAN LAMBDA LIGHT CHAIN REAGENT
Beckman Instruments, Inc.
Immunology
55d
Cleared
Nov 16, 1988
BECKMAN KAPPA LIGHT CHAIN REAGENT
Beckman Instruments, Inc.
Immunology
35d
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 510(k) Review Time - DFH Product Code
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 →