Product Code: DGC FDA class 2 21 CFR 866.5510

Ige, Antigen, Antiserum, Control

Immunology

The IgE Antigen, Antiserum, and Control is an immunological reagent used in clinical laboratories to detect and quantify IgE immunoglobulins, which are associated with allergic reactions, anaphylaxis, and parasitic infections. It is classified as FDA Class 2, requiring 510(k) premarket notification to establish substantial equivalence, and is regulated under 21 CFR 866.5510 within the Immunology specialty. The device is eligible for third-party 510(k) review.

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510(k)s

114

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DGC
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 114 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231151	Kenota 1 Total IgE; Kenota 1 (instrument)	May 31, 2024	Substantially Equivalent	Kenota, Inc.
K214068	Quantia IgE	Feb 21, 2023	Substantially Equivalent	Biokit, S.A.
K220178	Total Immunoglobulin E (IgE)	Mar 23, 2022	Substantially Equivalent	Beckman Coulter, Inc.
K193493	ADVIA Centaur Total IgE (tIgE)	Jan 15, 2020	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K161899	ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls	Jul 28, 2016	Substantially Equivalent	Phadia AB
K133404	IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH	Feb 24, 2014	Substantially Equivalent	Phadia AB
K063425	DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH	Feb 15, 2007	Substantially Equivalent	Dade Behring, Inc.
K050493	QUANTIA IGE	Aug 16, 2005	Substantially Equivalent	Biokit, S.A.
K042241	K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C	Dec 10, 2004	Substantially Equivalent	Kamiya Biomedical Co.
K034057	LACRYTEST	Mar 09, 2004	Substantially Equivalent	Adiatec SA
K032251	IMMUNETECH TOTAL IGE SYSTEM	Dec 19, 2003	Substantially Equivalent	Immunetech Corporation
K024210	IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR	Feb 24, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K010855	RANDOX IGE	May 15, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K002560	SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT	Oct 26, 2000	Substantially Equivalent	The Binding Site, Ltd.
K992528	BIOCHECK IGE ELISA, MODEL BC-1035	Sep 21, 1999	Substantially Equivalent	Biocheck, Inc.
K991316	TOUCH TEAR IGE MICROASSAY KIT	Aug 09, 1999	Substantially Equivalent	Touch Scientific, Inc.
K991945	PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01	Jul 28, 1999	Substantially Equivalent	Pharmacia & Upjohn Co.
K991787	N LATEX IGE MONO REAGENT	Jul 07, 1999	Substantially Equivalent	Dade Behring, Inc.
K983185	BOEHRINGER MANNHEIM TINA-QUANT IGE TEST	Nov 12, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K972697	AIA-PACK IGE II ASSAY	Oct 03, 1997	Substantially Equivalent	Tosoh Medics, Inc.
K964152	UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH	Apr 23, 1997	Substantially Equivalent	Pharmacia, Inc.
K940183	HY-TEC TOTAL IGE ENZYME IMMUNOASSAY	May 17, 1994	Substantially Equivalent	Hycor Biomedical, Inc.
K934594	MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM	Apr 21, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K933180	QUANTA LITE MITOCHONDRIA M2 ELISA	Aug 05, 1993	Substantially Equivalent	Inova Diagnostics, Inc.
K930890	COBAS(R) CORE IGE TOTAL EIA	Aug 05, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K930984	ACCESS(R) TOTAL IGE ASSAY	Jun 09, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K923832	PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION	Nov 25, 1992	Substantially Equivalent	Kabi Pharmacia, Inc.
K922047	IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064	Aug 05, 1992	Substantially Equivalent	Medix Biotech, Inc.
K920372	ACS TOTAL IGE IMMUNOASSAY	Apr 08, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K912800	KALLESTEAD TOTAL IGE MICROPLATE KIT	Jul 25, 1991	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K910419	BIOCLONE'S ELEGANCE IGE ELISA KIT	Jun 21, 1991	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K911631	PHARMACIA SPECIFIC IGE CONTROL	Apr 24, 1991	Substantially Equivalent	Pharmacia, Inc.
K910082	POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK	Mar 12, 1991	Substantially Equivalent	Quidel Corp.
K905612	VENTREX COATED TUBE IGE RADIOIMMUNOASSAY	Feb 21, 1991	Substantially Equivalent	Ventrex Laboratories, Inc.
K903738	QUIDEL ALLERGEN SCREEN POSITIVE CONTROL	Oct 15, 1990	Substantially Equivalent	Quidel Corp.
K903195	LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY	Aug 02, 1990	Substantially Equivalent	London Diagnostics, Inc.
K900244	3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8	Feb 21, 1990	Substantially Equivalent	3M Company
K900108	3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12	Feb 21, 1990	Substantially Equivalent	3M Company
K895914	ABBOTT IMX IGE	Nov 13, 1989	Substantially Equivalent	Abbott Laboratories
K895004	MILENIA(TM) TOTAL IGE (MKIE1,5)	Sep 28, 1989	Substantially Equivalent	Diagnostic Products Corp.
K895294	PROGENE IGE BEAD EIA	Sep 21, 1989	Substantially Equivalent	Progene Corp.
K893951	PHARMACIA CAP SYSTEM IGE RIA AND FEIA	Jul 14, 1989	Substantially Equivalent	Pharmacia, Inc.
K892197	ALATOP (TM) CATALOG # AKAL1	Jun 02, 1989	Substantially Equivalent	Diagnostic Products Corp.
K890530	N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)	Mar 27, 1989	Substantially Equivalent	Behring Diagnostics, Inc.
K885307	FLIPSCREEN (TM) TOTAL E IMMUNOASSAY	Mar 08, 1989	Substantially Equivalent	Alerchek, Inc.
K884545	DELFIA (TM) HIGE KIT	Nov 10, 1988	Substantially Equivalent	Pharmacia, Inc.
K882625	PHARMACIA IGE RIA ULTRA	Aug 08, 1988	Substantially Equivalent	Pharmacia, Inc.
K882626	PHARMACIA IGE EIA ULTRA	Aug 04, 1988	Substantially Equivalent	Pharmacia, Inc.
K881892	PHARMACIA IGE RIACT	Jun 10, 1988	Substantially Equivalent	Pharmacia, Inc.
K874541	RRT TOTAL IGE TEST KIT	Feb 17, 1988	Substantially Equivalent	Incstar Corp.
K874406	IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064	Nov 25, 1987	Substantially Equivalent	Medix Biotech, Inc.
K872913	ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5	Sep 10, 1987	Substantially Equivalent	Diagnostic Products Corp.
K872968	ULTRASCAN IGE ASSAY KIT	Aug 28, 1987	Substantially Equivalent	Specialty Medical Industries, Inc.
K864142	UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE	Dec 03, 1986	Substantially Equivalent	United Biotech, Inc.
K863858	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--	Nov 03, 1986	Substantially Equivalent	Hybritech, Inc.
K863822	ENZYMUN-TEST(R) IGE	Oct 29, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K862174	TIMOTHY ALLERGEN DISC	Aug 06, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862368	AMPLIFIED ELISA IGE KIT	Jul 03, 1986	Substantially Equivalent	Allertec, Inc.
K861171	QUIDEL ALLERGY SCREEN	Apr 25, 1986	Substantially Equivalent	Quidel Corp.
K860032	TOTAL IGE-IRMA RIA KIT	Apr 11, 1986	Substantially Equivalent	Diagnostic Products Corp.
K860033	EIA MONOCLONAL TOTAL IGE KIT	Apr 07, 1986	Substantially Equivalent	Diagnostic Products Corp.
K852878	THE DPC MONOCLONAL EIA TOTAL IGE KIT	Aug 28, 1985	Substantially Equivalent	Diagnostic Products Corp.
K853025	IMAGE-IGE	Aug 22, 1985	Substantially Equivalent	Clinical Reference Laboratory, Inc.
K852268	QUANTICLONE IGE RADIOIMMUNASSAY	Jul 10, 1985	Substantially Equivalent	Kallestad Laboratories, Inc.
K851156	PHARMACIA IGE RIA MODIFIED	Apr 25, 1985	Substantially Equivalent	Pharmacia, Inc.
K850786	TOTAL HIGE ENZYME IMMUNOASSAY	Apr 12, 1985	Substantially Equivalent	Nms Pharmaceuticals, Inc.
K843369	AGGLUTINATION TEST FOR TOTAL IGE	Nov 14, 1984	Substantially Equivalent	Scientific Research
K843710	ELISA FOR TOTAL IGE	Oct 22, 1984	Substantially Equivalent	Scientific Research
K843408	ENCORE IGE REAGENT	Oct 01, 1984	Substantially Equivalent	Hybritech, Inc.
K842125	ALLERCOAT ALLERGEN DISCS	Jun 07, 1984	Substantially Equivalent	Kallestad Laboratories, Inc.
K841829	PHADEBAS RAST PHADEZYM RAST ALLERGEN	Jun 07, 1984	Substantially Equivalent	Pharmacia, Inc.
K841824	PHARMACIA IGE RIA	Jun 07, 1984	Substantially Equivalent	Pharmacia, Inc.
K841642	MAST LUMINESCENT ALLERGY SYS	Jun 07, 1984	Substantially Equivalent	Mast Immunosystems
K841651	VAST VENTREX RAST ALL	Jun 01, 1984	Substantially Equivalent	Ventrex Laboratories, Inc.
K840476	PHADEXACT SERUM, TOTAL IGE CONTROLS	May 21, 1984	Substantially Equivalent	Pharmacia, Inc.
K840674	SENSIBEAD EIA IGE KIT	Apr 04, 1984	Substantially Equivalent	Terumo Medical Corp.
K840538	PHADEXACT SERUM, ALLERGEN SPECIFIC IGE	Mar 23, 1984	Substantially Equivalent	Pharmacia, Inc.
K834594	TOTAL IGE FAST TEST	Feb 10, 1984	Substantially Equivalent	Allergenetics
K833419	LABELED 125I ANTI-IGE	Feb 03, 1984	Substantially Equivalent	Allergenetics
K833969	MAST TOTAL IGE	Jan 04, 1984	Substantially Equivalent	Mast Immunosystems
K832345	POLYSTYRENE MICROTITER WELL IMMUNOSOR	Nov 25, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K832360	ABBOTT IGE EIA	Oct 14, 1983	Substantially Equivalent	Abbott Laboratories
K832218	ALLERGEN CONTROL INHALENT	Sep 20, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K831485	VENTRE/ZYME IGE KIT	Jun 02, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K831377	IGE RADIOIMMUNOASSAY KIT	Jun 02, 1983	Substantially Equivalent	American Diagnostic Corp.
K831326	ALLERCOAT ALLERGEN DISCS	Jun 02, 1983	Substantially Equivalent	Kallestad Laboratories, Inc.
K831208	IGE-QUANT DIAGNOSTIC TEST KIT	May 09, 1983	Substantially Equivalent	Leeco Diagnostics, Inc.
K830817	NEW ALLERGEN DISCS FOR USE IN VAST VENT	Apr 27, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K830357	RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E	Mar 17, 1983	Substantially Equivalent	Clinetics Corp.
K830164	DENSITOMETRIC INHALENT PROFILE SLLER	Mar 01, 1983	Substantially Equivalent	Mast Immunosystems
K823494	TOTAL IGE-FAST TEST	Jan 14, 1983	Substantially Equivalent	Axonics, Inc.
K823842	PHADEZYM RAST ALLERGEN DISCS	Jan 12, 1983	Substantially Equivalent	Pharmacia, Inc.
K823841	PHADEBAS RAST ALLERGEN DISCS	Jan 12, 1983	Substantially Equivalent	Pharmacia, Inc.
K823507	TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY	Dec 28, 1982	Substantially Equivalent	Hybritech, Inc.
K823403	ALLERCOAT POSITIVE CONTROL SERUM	Dec 15, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K822341	ALLERGENETICS IGE-FAST TEST	Nov 10, 1982	Substantially Equivalent	Allergenetics
K822613	RAST ALLERCOAT ALLERGEN DISCS	Oct 22, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K822442	VAST VENTREX RAST ALLERGEN DISCS	Sep 02, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K822206	TOTAL IGE DISCS	Aug 16, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K821092	GAMMADAB[125]EGE RADIOIMMUNOASSAY IT	Jun 22, 1982	Substantially Equivalent	Clinical Assays, Inc.
K820978	VENTRE/SPEC ALLERGEN CONTROL-INHALANT	Jun 11, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K820977	VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD	Jun 11, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K821615	VAST VENTREX PD IGE RIA TEST SET	Jun 10, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K820897	VENTRE/SPEC IGE CONTROLS	May 05, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K820896	VENTREX 125I ANTI-IGE ALLERGY ISOTOPE	Apr 21, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K813189	PHADEBAS/PHADEZYM IGE REAGENTS	Dec 31, 1981	Substantially Equivalent	Pharmacia, Inc.
K811559	VENTRE/SEP IGE RIA TEST SET	Jul 10, 1981	Substantially Equivalent	Ventrex Laboratories, Inc.
K811545	KALLESTAD QUANTITOPE LOW LEVEL IGE REAG	Jun 24, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K802913	TAN DEM* - IGE KIT	May 29, 1981	Substantially Equivalent	Hybritech, Inc.
K810507	PHADEZYM IGE PRIST TEST	Mar 20, 1981	Substantially Equivalent	Pharmacia, Inc.
K801019	125I-IGE RADIOIMMUNOASSAY KIT	May 20, 1980	Substantially Equivalent	Bio-Ria
K781904	RIA KIT, QUANTITOPE IGE	Feb 08, 1979	Substantially Equivalent	Kallestad Laboratories, Inc.
K780753	LAS-R HUMAN IGE TEST	Jun 06, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K771238	RID PLATES & INTENSI. FOR HUMAN IGE ETC	Jul 15, 1977	Substantially Equivalent	G.D. Searle and Co.