Product Code: DEW FDA class 2 21 CFR 866.5510

Igg, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring immunoglobulin G (IgG), the predominant immunoglobulin in human serum and the primary mediator of secondary humoral immune responses, using antigen, antiserum, and control components for clinical immunoassay testing. IgG levels are measured to evaluate immune deficiency, autoimmune disorders, and hypergammaglobulinemia. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEW, regulated under 21 CFR 866.5510, within the Immunology specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DEW
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 76 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050113	TINA-QUANT IGG GEN.2	Feb 08, 2005	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K040434	ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2	Mar 10, 2004	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K010617	SPIFE IFE CALIBRATOR AND CONTROL KIT	Mar 15, 2001	Substantially Equivalent	HELENA LABORATORIES
K993928	WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD	Jan 18, 2000	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K993281	K-ASSAY IGG	Nov 09, 1999	Substantially Equivalent	KAMIYA BIOMEDICAL CO.
K983221	IGG	Nov 04, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K965108	SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT	Mar 06, 1997	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K963974	IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN	Mar 06, 1997	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K963868	IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)	Feb 10, 1997	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K962202	QUANTEX IGG	Sep 26, 1996	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K955798	IGG IMMUNOTURBIDIMETRIC & CALIBRATOR	Apr 05, 1996	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K951635	BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL	May 15, 1995	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K943997	BEHRING NEPHELOMETER II	Oct 03, 1994	Substantially Equivalent	BEHRING DIAGNOSTICS, INC.
K934324	OT IGG SORBENT	Apr 21, 1994	Substantially Equivalent	ORGANON TEKNIKA CORP.
K933314	RADIAS FERRITIN ENZYME IMMUNOASSAY	Sep 08, 1993	Substantially Equivalent	BIO-RAD
K924197	ZORBA(TM) IGG REMOVAL REAGENT	Dec 15, 1992	Substantially Equivalent	ZEUS SCIENTIFIC, INC.
K921575	IGG SUCLASS EIA	May 28, 1992	Substantially Equivalent	VIROTECH DIAGNOSTIKA
K911610	ELISA COMBI-KIT HUMAN IGG SUBCLASSES	Jun 12, 1991	Substantially Equivalent	JANSSEN RESEARCH FOUNDATION
K900943	MODIFIED TECHNICON DPA-1(TM) SYSTEM	Apr 26, 1990	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K893419	COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)	Aug 03, 1989	Substantially Equivalent	COULTER IMMUNOLOGY
K891385	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)	Apr 18, 1989	Substantially Equivalent	VITEK SYSTEMS, INC.
K890416	SPQ(TM) ANTIBODY REAGENT SET II FOR IGG	Feb 22, 1989	Substantially Equivalent	ATLANTIC ANTIBODIES
K882369	ACCRAASSAY RID KITS	Jul 12, 1988	Substantially Equivalent	ICN IMMUNOBIOLOGICALS
K882083	QM300 IGG ANTIBODY PACK	Jul 08, 1988	Substantially Equivalent	KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
K880784	WAKO(TM) IGG-HA DIRECT	Jun 06, 1988	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K875254	GULLSORB IGG INACTIVATION REAGENT	Feb 17, 1988	Substantially Equivalent	GULL LABORATORIES, INC.
K875356	IMMUNOGLOBULIN G & G SUBCLASSES	Feb 10, 1988	Substantially Equivalent	BIRMINGHAM
K873870	IMMUNOGLOBULINS G	Oct 13, 1987	Substantially Equivalent	UNIPATH LTD.
K872800	TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT	Aug 12, 1987	Substantially Equivalent	ABBOTT LABORATORIES
K871352	PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS	Apr 22, 1987	Substantially Equivalent	HELENA LABORATORIES
K871340	QM300 IGG ANTIBODY PACK	Apr 22, 1987	Substantially Equivalent	KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
K862764	TINA-QUANT(R) IGG	Sep 03, 1986	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K861059	DAKO ITA SYSTEM	Aug 25, 1986	Substantially Equivalent	DAKO CORP.
K853465	GILFORD IMMUNOGLOBULIN G REAGENT	Sep 16, 1985	Substantially Equivalent	GILFORD
K852589	TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT	Jul 15, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K851541	DART IMMUNOGLOBULINS REAGENT SYSTEM	Jul 15, 1985	Substantially Equivalent	COULTER ELECTRONICS, INC.
K850583	SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G	Mar 01, 1985	Substantially Equivalent	APPLICATIONS LAB
K842329	AMER. HISTO-ID SYS PRIMARY IGG S7920-11	Aug 02, 1984	Substantially Equivalent	BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
K841816	OPTIMATE IGG TEST	Jun 22, 1984	Substantially Equivalent	MILES LABORATORIES, INC.
K833402	TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN	Jan 24, 1984	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K832258	GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC	Oct 31, 1983	Substantially Equivalent	GELCO DIAGNOSTICS, INC.
K832264	FITC GOAT ANTI-HUMAN IGG Y CHAIN	Oct 28, 1983	Substantially Equivalent	GELCO DIAGNOSTICS, INC.
K831101	TIA-IGG REAGENT & CALIBRATOR SETS	Apr 27, 1983	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K830594	TITAN IMMUNO-FIX	Mar 24, 1983	Substantially Equivalent	HELENA LABORATORIES
K821018	ANTIHUMAN IGG GLOBULIN FITC LABELED	Apr 29, 1982	Substantially Equivalent	MICROBIOLOGICAL RESEARCH CORP.
K812484	DAKO PAP KIT K505	Feb 10, 1982	Substantially Equivalent	DAKO CORP.
K812664	ACA IMMUNOGLOBULIN G ANALYTICAL TEST	Oct 02, 1981	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K812630	ACA IMMUNOGLOBULIN G CALIBRATOR	Sep 29, 1981	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K812495	IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA	Sep 23, 1981	Substantially Equivalent	DAKO CORP.
K812489	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG	Sep 23, 1981	Substantially Equivalent	DAKO CORP.
K812453	SCRIPPSYSTEM IMMUNOGLOBIN RID KIT	Sep 23, 1981	Substantially Equivalent	SCRIPPS-MILES, INC.
K812328	SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT	Sep 08, 1981	Substantially Equivalent	SCRIPPS-MILES, INC.
K810694	PHADEBAS IGG RAST TEST	Jul 23, 1981	Substantially Equivalent	PHARMACIA, INC.
K811126	AIM SYSTEM (FOR IGG)	May 08, 1981	Substantially Equivalent	ICL SCIENTIFIC
K810056	IMMUNOLOGY CONTROL SERUM	Feb 09, 1981	Substantially Equivalent	ICL SCIENTIFIC
K802257	GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC	Oct 31, 1980	Substantially Equivalent	PROTOS LABORATORIES
K801281	J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI	Jun 20, 1980	Substantially Equivalent	J.T. BAKER CHEMICAL CO.
K800897	RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.	May 08, 1980	Substantially Equivalent	ICL SCIENTIFIC
K800451	GEMENI IGG ASSAY	Apr 24, 1980	Substantially Equivalent	ELECTRO-NUCLEONICS LABORATORIES, INC.
K800398	PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT	Mar 12, 1980	Substantially Equivalent	DIAGNOSTICA, INC.
K800119	IMMUNOGLOBULIN G REAGENT SYSTEM	Feb 05, 1980	Substantially Equivalent	CALBIOCHEM-BEHRING CORP.
K791281	ANTI-HUMAN IGG SERUM	Nov 27, 1979	Substantially Equivalent	DIAGNOSTICA, INC.
K791824	ANTISERUM TO HUMAN IMMUNOGLOBULINS	Oct 17, 1979	Substantially Equivalent	ICL SCIENTIFIC
K791403	LANCER L-INA ANTI-IGG	Oct 17, 1979	Substantially Equivalent	SHERWOOD MEDICAL CO.
K791285	ANTI-HUMAN GLOBULINS	Oct 17, 1979	Substantially Equivalent	DIAGNOSTICA, INC.
K790702	ANTISERUM, HUMAN, IGG H & L CHAIN	Sep 04, 1979	Substantially Equivalent	KENT LABORATORIES, INC.
K790704	ANTISERUM TO HUMAN IGG	Apr 12, 1979	Unknown	KENT LABORATORIES, INC.
K772077	RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G	Feb 03, 1978	Substantially Equivalent	GELMAN INSTRUMENT CO.
K772252	IMMUNOGLOBULIN G NEPHEL. ASSAY	Dec 22, 1977	Substantially Equivalent	KALLESTAD LABORATORIES, INC.
K770961	GOAT ANTISERUM IGG NEPHELOMETRIC	Jun 24, 1977	Substantially Equivalent	KALLESTAD LABORATORIES, INC.
K770669	RHODAMINE-CONJUGATED ANTISERUM	Apr 28, 1977	Substantially Equivalent	KENT LABORATORIES, INC.
K770668	FLUORESCEIN CONJUGATED ANTISERUM	Apr 28, 1977	Substantially Equivalent	KENT LABORATORIES, INC.
K770597	DASP TM ANTI-RABBIT	Apr 28, 1977	Substantially Equivalent	ORGANON, INC.
K761224	ULTRA LOW LEVEL IMMUNOGLOBULIN G	Apr 07, 1977	Substantially Equivalent	INTL. DIAGNOSTIC TECHNOLOGY
K770484	FLUOR. CONJUGATED ANTISERUM	Mar 21, 1977	Substantially Equivalent	KENT LABORATORIES, INC.
K760145	SERUM, IGG GOAT ANTI-HUMAN ACID	Jul 19, 1976	Substantially Equivalent	OXFORD LABORATORIES, INC.

FEI Numbers

This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

1000403749: 44 registrations

1181121: 182 registrations

1524213: 76 registrations

2050010: 124 registrations

2050012: 131 registrations

2084025: 42 registrations

2242436: 129 registrations

3000148879: 72 registrations

3001644026: 148 registrations

3002806559: 387 registrations

3002806560: 8 registrations

3002806778: 50 registrations

3002808340: 97 registrations

3002809144: 150 registrations

3003261083: 5 registrations

3003423869: 54 registrations

3003601075: 10 registrations

3003795116: 46 registrations

3004493545: 205 registrations

3005094123: 56 registrations

3005333358: 273 registrations

3006198300: 142 registrations

3008237827: 79 registrations

3009189893: 82 registrations

3012471076: 98 registrations

3013059683: 46 registrations

3016438761: 72 registrations

3019906: 71 registrations