Product Code: DFH FDA class 2 21 CFR 866.5550

Kappa, Antigen, Antiserum, Control

Immunology

The Kappa Antigen, Antiserum, and Control is an immunological reagent used in clinical laboratories to detect and measure kappa light chains, which are components of immunoglobulin molecules. This product falls under FDA Class 2, indicating it is a moderate-risk device subject to general controls and special controls, and manufacturers must submit a 510(k) premarket notification before marketing. It is regulated under 21 CFR 866.5550 and classified within the Immunology medical specialty. This device is eligible for third-party 510(k) review, allowing an FDA-recognized accredited organization to conduct the initial review in place of FDA.

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Basic Information

Product Code: DFH
Device Class: FDA class 2
Regulation Number: 866.5550
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253358	Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay	Dec 19, 2025	Substantially Equivalent	Diazyme Laboratories, Inc.
K250549	Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit	May 23, 2025	Substantially Equivalent	The Binding Site Group , Ltd.
K231601	FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2	Feb 23, 2024	Substantially Equivalent	Sebia
K231290	Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit	Jan 24, 2024	Substantially Equivalent	The Binding Site, Ltd.
K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	Nov 18, 2022	Substantially Equivalent	Sebia
K211648	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	Sep 08, 2022	Substantially Equivalent	Diazyme Laboratories, Inc.
K220001	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	Aug 04, 2022	Substantially Equivalent	Diazyme Laboratories, Inc.
K212379	N Latex FLC kappa, N Latex FLC lambda	Mar 02, 2022	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K201496	N Latex FLC kappa, N Latex FLC lambda	Oct 29, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K193047	N Latex FLC kappa, N Latex FLC lambda	Jul 14, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K190879	N Latex FLC kappa, N Latex FLC lambda	May 03, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K182098	N Latex FLC kappa assay, N Latex FLC lambda assay	Nov 01, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K173732	Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit	Aug 23, 2018	Substantially Equivalent	The Binding Site Group , Ltd.
K181438	Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay	Jun 26, 2018	Substantially Equivalent	Diazyme Laboratories, Inc.
K171742	N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2	Nov 17, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K153394	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator	Nov 18, 2016	Substantially Equivalent	Diazyme Laboratories
K150658	Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit	Aug 26, 2015	Substantially Equivalent	The Binding Site Group , Ltd.
K120056	HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER	Apr 01, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K083602	KAPPA LIGHT CHAINS	Sep 03, 2009	Substantially Equivalent	SENTINEL CH. SpA
K082503	DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL	Dec 19, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K070900	FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT	Nov 30, 2007	Substantially Equivalent	The Binding Site, Ltd.
K062372	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER	Jun 21, 2007	Substantially Equivalent	The Binding Site, Ltd.
K051915	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER	Sep 06, 2005	Substantially Equivalent	The Binding Site, Ltd.
K042939	CAPILLARY'S IMMUNOTYPING (PN 2100)	Jun 27, 2005	Substantially Equivalent	Sebia, Inc.
K040009	FREELITE HUMAN KAPPA AND LAMBDA KITS	Mar 11, 2004	Substantially Equivalent	The Binding Site, Ltd.
K023009	FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER	Jan 21, 2003	Substantially Equivalent	The Binding Site, Ltd.
K003669	KAPPA IMMAGE FREELITE KIT	Feb 01, 2001	Substantially Equivalent	The Binding Site, Ltd.
K002564	SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT	Oct 26, 2000	Substantially Equivalent	The Binding Site, Ltd.
K964260	IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG	Feb 10, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K950152	CHEMMATE(TM) UCHL1 (CD45-RO)	Oct 27, 1995	Substantially Equivalent	Biotek Solutions, Inc.
K950150	CHEMMATE(TM) KAPPA	Oct 27, 1995	Substantially Equivalent	Biotek Solutions, Inc.
K902484	BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)	Jun 21, 1990	Substantially Equivalent	Beckman Instruments, Inc.
K884597	BECKMAN LAMBDA LIGHT CHAIN REAGENT	Dec 06, 1988	Substantially Equivalent	Beckman Instruments, Inc.
K884276	BECKMAN KAPPA LIGHT CHAIN REAGENT	Nov 16, 1988	Substantially Equivalent	Beckman Instruments, Inc.
K880341	N-IMMUNOGLOBULIN LIGHT CHAIN KIT	Feb 17, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K875164	QM300 KAPPA LIGHT CHAINS ANTIBODY PACK	Jan 22, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K855008	QUANTIMETRIC PLUS KAPPA REAGENT KIT	Feb 26, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K842470	TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM	Aug 28, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K842326	AMER. HISTO-ID SYS PRIMARY KIT	Aug 02, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K832266	FITC GOAT ANTI-HUMAN KAPPA AFFINITY	Oct 31, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K832256	GOAT ANTI-HUMAN IMMUNOGLOBULINS-	Oct 31, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K823121	RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822679	FITC ANTISERA TO HUMAN C3	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822678	FITC ANTISERA TO HUMAN GOBULIN	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822677	FITC ANTISERA TO HUMAN IGM	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822676	FITC ANTISERA TO HUMAN IGG	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822675	FITC ANTISERA TO HUMAN IGA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822674	FITC ANTISERA TO HUMAN LAMBDA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822673	FITC ANTISERA TO HUMAN KAPPA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822671	ANTISERUM TO HUMAN GOBULIN	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822670	ANTISERUM TO HUMAN IGM	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822669	ANTISERUM TO HUMAN IGG	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822668	ANTISERUM TO HUMAN IGA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822667	ANTISERUM TO HUMAN LAMBDA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K822666	ANTISERUM TO HUMAN KAPPA	Nov 17, 1982	Substantially Equivalent	Amico Lab, Inc.
K812485	DAKO PAP KIT K504	Feb 10, 1982	Substantially Equivalent	Dako Corp.
K812661	IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA	Sep 29, 1981	Substantially Equivalent	Dako Corp.
K811721	H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME	Jul 16, 1981	Substantially Equivalent	Immulok, Inc.
K802283	ANTISERA TO HUMAN FREE KAPPA CHAINS	Oct 23, 1980	Substantially Equivalent	Kallestad Laboratories, Inc.
K791284	ANTI-HUMAN KAPPA SERUM	Nov 27, 1979	Substantially Equivalent	Diagnostica, Inc.
K790706	ANTISERUM TO RABBIT IGG H & L CHAIN	Sep 12, 1979	Substantially Equivalent	Kent Laboratories, Inc.
K781028	KAPPA SERUM (FREE & BOUND) ANTI-HUMAN	Jul 27, 1978	Substantially Equivalent	Icl Scientific
K781027	KAPPA SERUM (FREE) ANTI-HUMAN	Jul 27, 1978	Substantially Equivalent	Icl Scientific