Product Code: CFN FDA class 2 21 CFR 866.5510

Method, Nephelometric, Immunoglobulins (G, A, M)

Immunology

The Nephelometric Immunoglobulins (G, A, M) Method is an immunology device that measures IgG, IgA, and IgM concentrations in serum by nephelometry, detecting light scattered by antigen-antibody complexes formed when patient immunoglobulins react with specific antisera, used in the quantitative assessment of humoral immune status and diagnosis of immunodeficiency or gammopathy. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CFN, regulated under 21 CFR 866.5510, within the Immunology medical specialty. This device is eligible for third-party review.

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Basic Information

Product Code: CFN
Device Class: FDA class 2
Regulation Number: 866.5510
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233663	N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)	Dec 13, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K221114	Immunoglobulin G (IgG)	Aug 02, 2023	Substantially Equivalent	Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
K192116	Human IgA liquid reagent kit for Use on SPAPlus	Sep 04, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K191985	Optilite IgA Kit	Aug 19, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K191635	Optilite IgM Kit	Jul 15, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K191465	Human IgM Kit for use on SPAPlus	Jun 27, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K190686	Optilite IgM CSF Kit	May 28, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K183151	Optilite IgA CSF Kit	Jan 23, 2019	Substantially Equivalent	The Binding Site Group , Ltd.
K162208	DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent	Jan 09, 2017	Substantially Equivalent	Beckman Coulter, Inc.
K150526	Optilite IgG4 Kit	May 30, 2015	Substantially Equivalent	The Binding Site Group , Ltd.
K142735	The Optilite IgG3 kit	Dec 21, 2014	Substantially Equivalent	The Binding Site Group , Ltd.
K130122	BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER	Jan 07, 2014	Substantially Equivalent	Beckman Coulter, Inc.
K120901	HUMAN IGA CSF KIT FOR USE ON SPAPLUS	May 30, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K120750	HUMAN IGM CSF KIT	May 17, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K120749	HUMAN IGG CSF KIT	May 17, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K113823	HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT	Mar 27, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K103824	HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS	Feb 27, 2012	Substantially Equivalent	The Binding Site
K100588	HUMAN IGA2 KIT FOR USE ON THE SPAPLUS	Aug 16, 2010	Substantially Equivalent	The Binding Site Group , Ltd.
K082823	HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS	Mar 01, 2010	Substantially Equivalent	The Binding Site Group , Ltd.
K090920	HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)	Dec 30, 2009	Substantially Equivalent	The Binding Site, Ltd.
K090594	DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID	Apr 29, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K083445	N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC	Mar 24, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K082129	HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER	Feb 10, 2009	Substantially Equivalent	The Binding Site, Ltd.
K081827	HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS	Dec 19, 2008	Substantially Equivalent	The Binding Site, Ltd.
K081161	DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST	Jul 28, 2008	Substantially Equivalent	Dade Behring, Inc.
K073561	DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR	Feb 26, 2008	Substantially Equivalent	Dade Behring, Inc.
K073490	OLYMPUS IGG REAGENT	Feb 11, 2008	Substantially Equivalent	Olympus America, Inc.
K073489	OLYMPUS IGA REAGENT	Feb 11, 2008	Substantially Equivalent	Olympus America, Inc.
K073487	OLYMPUS IGM REAGENT	Feb 11, 2008	Substantially Equivalent	Olympus America, Inc.
K072889	HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER	Feb 01, 2008	Substantially Equivalent	The Binding Site, Ltd.
K061845	DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H	Aug 24, 2006	Substantially Equivalent	Dade Behring, Inc.
K061338	DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY	Jul 06, 2006	Substantially Equivalent	Dade Behring, Inc.
K042735	N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)	Feb 15, 2005	Substantially Equivalent	Dade Behring, Inc.
K042152	BINDING SITE IGG SUBLCASS OLYMPUS KITS	Nov 22, 2004	Substantially Equivalent	The Binding Site
K042475	VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC	Nov 10, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K032014	N LATEX IGM	Aug 07, 2003	Substantially Equivalent	Dade Behring, Inc.
K022083	HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER	Jul 16, 2002	Substantially Equivalent	The Binding Site, Ltd.
K012296	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T	Aug 31, 2001	Substantially Equivalent	The Binding Site, Ltd.
K012292	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB	Aug 31, 2001	Substantially Equivalent	The Binding Site, Ltd.
K012295	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T	Aug 20, 2001	Substantially Equivalent	The Binding Site, Ltd.
K012291	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA	Aug 20, 2001	Substantially Equivalent	The Binding Site, Ltd.
K000701	HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER	Apr 27, 2000	Substantially Equivalent	The Binding Site, Ltd.
K993549	BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR	Feb 01, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993547	BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB	Feb 01, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993924	WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD	Jan 14, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K981784	IGM MININEPH ANTISERUM	Dec 21, 1999	Substantially Equivalent	The Binding Site, Ltd.
K982100	IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS	Dec 20, 1999	Substantially Equivalent	The Binding Site, Ltd.
K981912	HUMAN IGA SUBCLASS BNII COMBI KIT	Dec 04, 1998	Substantially Equivalent	The Binding Site, Ltd.
K982382	COBAS INTEGRA REAGENT CASSETTES	Sep 28, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K933971	N-ASSAY TIA IGA	Mar 22, 1994	Substantially Equivalent	Crestat Diagnostics, Inc.
K933970	N-ASSAY TIA IGM	Mar 22, 1994	Substantially Equivalent	Crestat Diagnostics, Inc.
K933973	N-ASSAY TIA MULTI V-NL	Jan 28, 1994	Substantially Equivalent	Crestat Diagnostics, Inc.
K923070	WAKO IGG-HA	Aug 20, 1992	Substantially Equivalent	Wako Chemicals USA, Inc.
K880356	N PROTEIN STANDARD PLASMA (HUMAN)	Apr 07, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K871343	QM2/QM300 BUFFER AND DILUENT PACK	May 15, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K864342	MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX	Dec 01, 1986	Substantially Equivalent	Eiken Chemical Co., Inc.
K860894	BEHRING NEPHELOMETER SYSTEM	Apr 15, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K781656	NEPHELRATE ANTISERUMS, IGG	Nov 08, 1978	Substantially Equivalent	Antibodies, Inc.
K781655	NEPHELRATE ANTISERUMS 1GA	Nov 08, 1978	Substantially Equivalent	Antibodies, Inc.
K781654	NEPHELRATE ANTIPERUMS LGM	Nov 08, 1978	Substantially Equivalent	Antibodies, Inc.
K771226	LAS-R TEST PROGRAM	Jul 21, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories