Product Code: CIX FDA class 2 21 CFR 862.1035

Bromcresol Green Dye-Binding, Albumin

Clinical Chemistry

The Bromcresol Green Dye-Binding, Albumin test system (product code CIX) is an in-vitro diagnostic device used in clinical chemistry to measure albumin concentrations in serum using the bromcresol green (BCG) dye-binding colorimetric method, one of the most widely used techniques for serum albumin quantification. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1035 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

119

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CIX
Device Class: FDA class 2
Regulation Number: 862.1035
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 119 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203248	Albumin BCG2	Nov 23, 2021	Substantially Equivalent	Abbott Ireland Diagnostics Division
K200898	Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin	Sep 21, 2021	Substantially Equivalent	Medicon Hellas, S.A
K191316	VITROS XT Chemistry Products ALB-TP Slides	Jun 07, 2019	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K170901	ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400	Apr 13, 2018	Substantially Equivalent	BioSystems S.A.
K131488	ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT	Aug 19, 2013	Substantially Equivalent	ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
K113374	ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT	Jul 13, 2012	Substantially Equivalent	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K110818	POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS	Sep 08, 2011	Substantially Equivalent	POLYMEDCO, INC.
K110830	ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH	Jun 21, 2011	Substantially Equivalent	ELITECHGROUP
K101088	EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT	Apr 04, 2011	Substantially Equivalent	MEDICA CORP.
K080874	EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT	Feb 20, 2009	Substantially Equivalent	MEDICA CORP.
K072143	S40 CLINICAL ANALYZER, S TEST ALB	Jul 14, 2008	Substantially Equivalent	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K060434	ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL	Jun 05, 2007	Substantially Equivalent	HORIBA ABX
K033009	ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2	Oct 16, 2003	Substantially Equivalent	ROCHE DIAGNOSTICS CORP.
K030006	ATAC PAK ALBUMIN REAGENT	Mar 07, 2003	Substantially Equivalent	ELAN DIAGNOSTICS
K023875	VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4	Dec 10, 2002	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K022072	PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS	Aug 23, 2002	Substantially Equivalent	PRECISION SYSTEMS, INC.
K012329	WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300	Sep 21, 2001	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K011720	OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER	Jun 25, 2001	Substantially Equivalent	OLYMPUS AMERICA, INC.
K010877	CHEMWELL, MODEL 2900	May 23, 2001	Substantially Equivalent	AWARENESS TECHNOLOGY, INC.
K003327	ALBUMIN	Dec 05, 2000	Substantially Equivalent	JAS Diagnostics, Inc.
K992399	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Sep 15, 1999	Substantially Equivalent	BAYER CORP.
K991576	ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM	Jun 30, 1999	Substantially Equivalent	BAYER CORP.
K984494	RANDOX ALBUMIN	Mar 23, 1999	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K981758	ALBG	Jun 12, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K981468	ALBG	May 27, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K980041	CARESIDE ALBUMIN	Feb 04, 1998	Substantially Equivalent	EXIGENT DIAGNOSTICS, INC.
K971445	ALB OR ALBUMIN	May 02, 1997	Substantially Equivalent	CAROLINA LIQUID CHEMISTRIES CORP.
K955781	ALBUMIN	Mar 13, 1996	Substantially Equivalent	DERMA MEDIA LAB., INC.
K952488	TRACE COBAS MIRA RANGE	Oct 13, 1995	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K946355	DMA ALBUMIN PROCEDURE	Mar 01, 1995	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K943000	ALBUMIN QVET	Dec 13, 1994	Substantially Equivalent	PRISMA SYSTEMS
K935179	EMDS ALBUMIN (ALB) TEST	Dec 17, 1993	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K924368	OLYMPUS ALBUMIN REAGENT	Feb 08, 1993	Substantially Equivalent	OLYMPUS CORP.
K923959	ALBUMIN TEST	Dec 28, 1992	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K923322	TRACE ALBUMIN-MR REAGENT	Sep 11, 1992	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K922369	OLYMPUS ALBUMIN REAGENT	Jul 17, 1992	Substantially Equivalent	OLYMPUS CORP.
K914888	TECHNICON CHEM 1(TM) SYST (GEN2 SYST)	Nov 27, 1991	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K913920	ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37	Sep 27, 1991	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K913195	KODAK EKTACHEM DT SLIDES (ALB)	Aug 26, 1991	Substantially Equivalent	EASTMAN KODAK COMPANY
K905660	SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401	Jan 25, 1991	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K903543	SYNERMED ALBUMIN REAGENT KIT	Oct 12, 1990	Substantially Equivalent	SYNERMED, INC.
K901268	COULTER ALBUMIN REAGENT	May 30, 1990	Substantially Equivalent	COULTER CORP.
K896235	COBAS READY ALBUMIN REAGENT	Feb 27, 1990	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K896910	CLINISTAT ALBUMIN REAGENT TEST	Jan 18, 1990	Substantially Equivalent	MILES DIAGNOSTICS DIV.
K893777	ALBUMIN TEST (ALB) ITEM NUMBER: 65401	Aug 21, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K891375	IQ ALBUMIN	May 05, 1989	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K885094	BIOTROL ALBUMIN	Feb 10, 1989	Substantially Equivalent	BIOTROL, USA, INC.
K884705	ALBUMIN TEST (ALB) ITEM #65650	Jan 11, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K882587	A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM	Aug 08, 1988	Substantially Equivalent	A-KEM, INC.
K875207	ALBUMIN CAT. # 201-03	Apr 18, 1988	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K880844	ALBUMIN REAGENT SET	Apr 05, 1988	Substantially Equivalent	TECH-NEAL SCIENTIFIC, INC.
K880313	WAKO(TM) AUTOKIT ALBUMIN	Mar 24, 1988	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K875070	ALBUMIN, BROMCRESOL GREEN DYE-BINDING	Jan 11, 1988	Substantially Equivalent	TECH-CO, INC.
K874163	ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS	Nov 23, 1987	Substantially Equivalent	CATACHEM, INC.
K874049	MULTICHEM ALBUMIN REAGENT S0902	Oct 29, 1987	Substantially Equivalent	SIMMLER, INC.
K873994	EASY-TEST ALBUMIN (ALB), ITEM NO. 19039	Oct 29, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K870372	ALBUMIN REAGENT - BROMCRESOL GREEN METHOD	Aug 19, 1987	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K864715	EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93	Dec 31, 1986	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K863263	ALBUMIN PROCEDURE	Sep 15, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K863050	ALBUMETER	Sep 11, 1986	Substantially Equivalent	J. D. ASSOC.
K861654	ALBUMIN PROCEDURE	Jun 13, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K861467	ALBUMIN (BCG) REAGENT	May 23, 1986	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K860684	SANDARE BCG ALBUMIN PROCEDURE	Mar 17, 1986	Substantially Equivalent	SANDARE CHEMICAL CO., INC.
K860661	AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT	Mar 14, 1986	Substantially Equivalent	AMRESCO, INC.
K860340	SERUM ALBUMIN (BCG) REAGENT SET	Feb 19, 1986	Substantially Equivalent	STERLING DIAGNOSTICS, INC.
K860213	ALBUMIN REAGENT KIT	Feb 11, 1986	Substantially Equivalent	BIO-ANALYTICS LABORATORIES, INC.
K855158	ALBUMIN REAGENT SET	Jan 14, 1986	Substantially Equivalent	TECHNOSTICS INTL.
K854718	NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926	Dec 19, 1985	Substantially Equivalent	NOBEL SCIENTIFIC INDUSTRIES, INC.
K854181	IN-VITRO TEST DETERMINATION OF ALBUMIN	Nov 25, 1985	Substantially Equivalent	CLINICAL DATA, INC.
K853978	TDX AMYLASE	Oct 15, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K853868	ALBUMIN SR LIQUID STABLE REAGENT SET	Sep 30, 1985	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K853049	ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE	Aug 02, 1985	Substantially Equivalent	SIMMLER, INC.
K850931	ALBUMIN	Jun 26, 1985	Substantially Equivalent	DILAB, INC.
K852007	ALB BCG REAGENT	May 30, 1985	Substantially Equivalent	ALPKEM CORP.
K851308	ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S	Apr 17, 1985	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K844330	ALBUMIN REAGENT FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	ADVANCED BIOMEDICAL METHODS, INC.
K843831	ALBUMIN REAGENT SET	Oct 11, 1984	Substantially Equivalent	LIVONIA DIAGNOSTICS, INC.
K843104	ALBUMIN ASSAY KIT	Sep 07, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K843108	SYSTEMATE ALBUMIN	Aug 27, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K841063	ALBUMIN REAGENT SET	May 01, 1984	Substantially Equivalent	MEDICAL SPECIALTIES, INC.
K840782	ALBUMIN REAGENT	Apr 13, 1984	Substantially Equivalent	AMERICAN DADE
K840291	MCS ALBUMIN REAGENT	Mar 30, 1984	Substantially Equivalent	MEDILAB CORP.
K833699	ALBUMIN REAGENT CS-716	Jan 13, 1984	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K832747	ALBUMIN REAGENT SET	Oct 14, 1983	Substantially Equivalent	BIORENT DIAGNOSTIC, INC.
K831585	ALBUMIN REAGENT (BCG	Jun 16, 1983	Substantially Equivalent	REAGENTS APPLICATIONS, INC.
K830536	FLOW-PAC ALBUMIN REAGENT	Mar 24, 1983	Substantially Equivalent	AMRESCO, INC.
K823575	COBAS STANDARDS FOR ALBUMIN	Jan 07, 1983	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K823574	COBAS REAGENT FOR ALBUMIN	Jan 07, 1983	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K822471	PSI ALBUMIN REAGENT	Sep 14, 1982	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K821880	ULTRA CHEM ALB	Jul 14, 1982	Substantially Equivalent	HARLECO DIAGNOSTICS
K821193	ALBUMIN REAGENT SET	Jul 13, 1982	Substantially Equivalent	OMEGA MEDICAL ELECTRONICS
K821225	ALBUMIN REAGENT	May 21, 1982	Substantially Equivalent	HI CHEM, INC.
K813044	ULTRACHEM ALB, ITEM #64970	Nov 10, 1981	Substantially Equivalent	HARLECO
K812030	KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)	Aug 03, 1981	Substantially Equivalent	EASTMAN KODAK COMPANY
K811662	ALBUMIN TEST	Jun 25, 1981	Substantially Equivalent	KING DIAGNOSTICS, INC.
K803237	AMES SERA-PAK ALBUMIN REAGENT KIT	Jan 09, 1981	Substantially Equivalent	MILES LABORATORIES, INC.
K802436	CENTRIFICHEM ALBUMIN	Oct 31, 1980	Substantially Equivalent	UNION CARBIDE CORP.
K802157	BCG REAGENT SERUM ALBUMIN W/TECHNICON	Oct 10, 1980	Substantially Equivalent	PANMED, INC.
K801750	BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY	Sep 16, 1980	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K800678	REAGENTS FOR DETERM. ALBUMIN IN HUMAN	May 28, 1980	Substantially Equivalent	DIAGNOSTIC SOLUTIONS, INC.
K792482	CHEMISTRY ANALYZER REAGENTS	Jan 11, 1980	Substantially Equivalent	LABORATORY PRODUCTS, INC.
K792408	ELVI ALBUMIN	Dec 06, 1979	Substantially Equivalent	VOLU SOL MEDICAL INDUSTRIES
K792339	CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN	Dec 06, 1979	Substantially Equivalent	CONNECTICUT DIAGNOSTICS, LTD.
K781773	ALBUMIN REAGENT	Nov 22, 1978	Substantially Equivalent	GILFORD DIAGNOSTICS
K781441	BCG ALBUMIN REAGET	Oct 10, 1978	Substantially Equivalent	ANALYTICAL & RESEARCH CHEMICALS, INC.
K780092	ULTRACHEM ALBUMIN	Feb 07, 1978	Substantially Equivalent	HARLECO
K771828	ALBUMIN	Oct 25, 1977	Substantially Equivalent	GAMMA ENTERPRISES, INC.
K771475	MULTISTAT III ALBUMIN TEST	Sep 13, 1977	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K771259	ALBUMIN TEST, HMA ALBUMIN TEST	Aug 22, 1977	Substantially Equivalent	HYCEL, INC.
K771094	UNIPAK ALBUMIN	Jul 21, 1977	Substantially Equivalent	HARLECO
K770822	A-GENT ALBUMIN	Jul 11, 1977	Substantially Equivalent	ABBOTT LABORATORIES
K770816	ULTRACHEM ALBUMIN	Jul 11, 1977	Substantially Equivalent	HARLECO
K770451	ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL	May 03, 1977	Substantially Equivalent	ICN PHARMACEUTICALS, INC.
K761329	MT II SYSTEM - SERUM ALBUMIN	Mar 21, 1977	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K761028	AUTO-ALBUMIN REAG FOR ABBOTT ABA-100	Nov 30, 1976	Substantially Equivalent	HARLECO
K761026	AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL	Nov 30, 1976	Substantially Equivalent	HARLECO DIAGNOSTICS
K760543	BROMCRESOL GREEN	Nov 01, 1976	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K760473	REAGENT, ALBUMIN DETERMINATION	Oct 29, 1976	Substantially Equivalent	SIMMLER & SON, INC.
K760355	TEST, SEROSONIC ALBUMIN	Oct 05, 1976	Substantially Equivalent	MALLINCKRODT CRITICAL CARE

FEI Numbers

This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

1000122044: 23 registrations

1000136573: 169 registrations

1000206808: 104 registrations

1000305840: 46 registrations

1000305841: 51 registrations

1000442352: 72 registrations

1036362: 17 registrations

1181055: 73 registrations

1181121: 182 registrations

1220972: 44 registrations

1827821: 149 registrations

1832216: 187 registrations

2050010: 124 registrations

2050012: 131 registrations

2250051: 152 registrations

2432235: 462 registrations

3000148879: 72 registrations

3000215862: 96 registrations

3000308930: 136 registrations

3002642396: 139 registrations

3002806559: 387 registrations

3002806560: 8 registrations

3002806809: 96 registrations

3002809144: 150 registrations

3003071743: 72 registrations

3003593973: 38 registrations

3003795116: 46 registrations

3004192065: 40 registrations

3004493545: 205 registrations

3005094123: 56 registrations

3005146313: 63 registrations

3005333358: 273 registrations

3006198300: 142 registrations

3006716639: 13 registrations

3007662974: 42 registrations

3011989923: 99 registrations

3012963943: 138 registrations

3013660430: 64 registrations

3015550354: 517 registrations

3016438761: 72 registrations

5864: 44 registrations

Registration Numbers

This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.

1036362: 17 registrations

1063851: 72 registrations

1064608: 72 registrations