Product Code: CEK FDA class 2 21 CFR 862.1635

Biuret (Colorimetric), Total Protein

Clinical Chemistry

The Biuret Colorimetric Total Protein Test is a clinical chemistry device that measures total protein content in serum or plasma using the Biuret reaction, in which protein reacts with copper ions in alkaline solution to produce a purple-colored complex proportional to protein concentration, used in nutritional assessment and diagnosis of protein-related disorders. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CEK, regulated under 21 CFR 862.1635, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

116

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CEK
Device Class: FDA class 2
Regulation Number: 862.1635
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

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 116 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K992846	HICHEM TOTAL PROTEIN REAGENT	Oct 18, 1999	Substantially Equivalent	Elan Holdings, Inc.
K973108	TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50	Mar 02, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K980042	CARESIDE TOTAL PROTEIN	Feb 04, 1998	Substantially Equivalent	Exigent Diagnostics, Inc.
K971524	TOTAL PROTEIN OR TP	May 16, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K961864	CSF/URINE TOTAL PROTEIN	Oct 24, 1996	Substantially Equivalent	Teco Diagnostics
K955905	STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY	May 30, 1996	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K955936	TOTAL PROTEIN REAGENT	Mar 12, 1996	Substantially Equivalent	Derma Media Lab., Inc.
K950920	DUPONT DIMENSION TOTAL PROTEIN METHOD	Aug 11, 1995	Substantially Equivalent	Dupont Medical Products
K950234	TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2	Jun 14, 1995	Substantially Equivalent	Emd Chemicals, Inc.
K950128	TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2	May 15, 1995	Substantially Equivalent	Emd Chemicals, Inc.
K943004	TOTAL PROTEIN QVET	Dec 09, 1994	Substantially Equivalent	Prisma Systems
K941496	SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY	Oct 27, 1994	Substantially Equivalent	Solarcare, Inc.
K942424	DMA MICROPROTEIN PROCEDURE	Sep 06, 1994	Substantially Equivalent	Data Medical Associates, Inc.
K934841	URINARY/CEREBROSPINAL FLUID PROTEIN	Apr 06, 1994	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K935174	TOTAL PROTEIN TEST (TPRO)	Dec 16, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K921412	MICROPROTEIN REAGENT SET	Jan 21, 1993	Substantially Equivalent	Sterling Diagnostics, Inc.
K924659	OLYUMPUS TOTAL PROTEIN REAGENT	Dec 29, 1992	Substantially Equivalent	Olympus Corp.
K922467	SYNCHRON TOTAL PROTEIN TEST --MODIFIED	Nov 23, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K923267	SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000	Sep 09, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923266	NOVA TOTAL PROTEIN MODULE	Aug 12, 1992	Substantially Equivalent	Nova Biomedical Corp.
K922361	OLYMPUS TOTAL PROTEIN REAGENT	Jul 16, 1992	Substantially Equivalent	Olympus Corp.
K920531	WAKO AUTOKIT MICRO TP	Jul 14, 1992	Substantially Equivalent	Wako Chemicals USA, Inc.
K915380	MICROPROTEIN-PR	Feb 18, 1992	Substantially Equivalent	Sigma Diagnostics, Inc.
K914885	BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST	Jan 30, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K913225	URINE/CSF MICROPROTEIN REAGENT	Oct 11, 1991	Substantially Equivalent	Intersect Systems, Inc.
K913978	TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE	Oct 09, 1991	Substantially Equivalent	Beckman Instruments, Inc.
K912810	ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13	Jul 30, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905790	TOTAL PROTEIN REAGENT SET	Feb 21, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K905661	SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420	Jan 31, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K904603	QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM	Jan 25, 1991	Substantially Equivalent	Quantitative Medicine, Inc.
K903511	SYNERMED TOTAL PROTEIN REAGENT KIT	Sep 07, 1990	Substantially Equivalent	Synermed, Inc.
K901527	BIURET (COLORMETRIC), TOTAL PROTEIN	Jul 19, 1990	Substantially Equivalent	American Research Products Co.
K900733	PROTEIN TEST FOR URINE AND CSF	Jul 10, 1990	Substantially Equivalent	Elite Technology, Inc.
K897166	COULTER TOTAL PROTEIN REAGENT	Feb 23, 1990	Substantially Equivalent	Coulter Electronics, Inc.
K896230	COBAS READY TOTAL PROTEIN REAGENT	Feb 16, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896916	CLINISTAT TOTAL PROTEIN REAGENT TEST	Jan 19, 1990	Substantially Equivalent	Heraeus Kulzer, Inc.
K893915	EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420	Aug 31, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890618	COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT	May 22, 1989	Substantially Equivalent	Kenlor Industries, Inc.
K890868	DMA MICROPROTEIN PROCEDURE	Mar 20, 1989	Substantially Equivalent	Data Medical Associates, Inc.
K890278	TOTAL PROTEIN REAGENT	Mar 09, 1989	Substantially Equivalent	Sigma Chemical Co.
K890317	TOTAL PROTEIN REAGENT	Mar 08, 1989	Substantially Equivalent	Medical Analysis Systems, Inc.
K884703	TOTAL PROTEIN TEST (TP) ITEM #65670	Jan 23, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884225	TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS	Dec 09, 1988	Substantially Equivalent	A-Kem, Inc.
K881639	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)	Jul 08, 1988	Substantially Equivalent	Eastman Kodak Company
K882189	BIOTROL TOTAL PROTEIN H.P.	Jul 01, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K880677	TOTAL PROTEIN REAGENT SET	Mar 24, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K880312	WAKO(TM) AUTOKIT TOTAL PROTEIN	Mar 24, 1988	Substantially Equivalent	Wako Chemicals USA, Inc.
K875222	TOTAL PROTEIN	Jan 22, 1988	Substantially Equivalent	Catachem, Inc.
K874476	EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011	Nov 25, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870371	TOTAL PROTEIN REAGENT - BIURET METHOD	Aug 19, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K871975	MULTICHEM TOTAL PROTEIN REAGENT #S0928	Jun 05, 1987	Substantially Equivalent	Simmler, Inc.
K864743	BIURET (COLORIMETRIC), TOTAL PROTEIN	Jan 13, 1987	Substantially Equivalent	Tech-Co, Inc.
K863258	TOTAL PROTEIN PROCEDURE	Sep 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K863301	DEMAND TOTAL PROTEIN	Sep 26, 1986	Substantially Equivalent	Cooper Biomedical, Inc.
K863074	TOTAL PROTEINS	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K863005	EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95	Aug 29, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861508	WAKO MICRO TP	Aug 19, 1986	Substantially Equivalent	Wako Chemicals USA, Inc.
K861798	VISION TOTAL PROTEIN	Jun 17, 1986	Substantially Equivalent	Abbott Laboratories
K861663	TOTAL PROTEIN PROCEDURE	Jun 13, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K860917	EASY-TEST TOTAL PROTEIN (TP), #67513/93	Apr 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860426	A-GENT LIQUID TOTAL PROTEIN	Apr 03, 1986	Substantially Equivalent	Abbott Laboratories
K860341	TOTAL PROTEIN (BIURET) REAGENT SET	Feb 11, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855191	TOTAL PROTEIN REAGENT SET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K854717	NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928	Jan 14, 1986	Substantially Equivalent	Nobel Scientific Industries, Inc.
K853932	QUANTTEST TOTAL PROTEIN ASSAY	Dec 19, 1985	Substantially Equivalent	Quantimetrix Corp.
K853930	QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT	Dec 10, 1985	Substantially Equivalent	Quantimetrix Corp.
K854553	TOTAL PROTEIN	Nov 25, 1985	Substantially Equivalent	American Monitor Corp.
K853681	SIGMA 610 FOR PROTEIN IN URINE & CSF	Oct 28, 1985	Substantially Equivalent	Sigma Diagnostics, Inc.
K853244	TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE	Aug 12, 1985	Substantially Equivalent	Simmler, Inc.
K852844	AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC	Jul 22, 1985	Substantially Equivalent	American Research Products Co.
K850936	TOTAL PROTEINS	Jun 25, 1985	Substantially Equivalent	Dilab, Inc.
K852006	TP BIURET REAGENT	Jun 10, 1985	Substantially Equivalent	Alpkem Corp.
K851877	TOTAL PROTEIN LIQUID STABLE REAGENT SET	May 20, 1985	Substantially Equivalent	Medical Analysis Systems, Inc.
K844331	TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K843701	TOTAL PROTEIN REAGENT SET	Oct 01, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843107	SYSTEMATE TOTAL PROTEIN 67218	Aug 27, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K843028	TOTAL PROTEIN ASSAY KIT	Aug 27, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841466	TOTAL PROTEIN REAGENT BIURET	May 16, 1984	Substantially Equivalent	Reagents Applications, Inc.
K841069	SERUM TOTAL PROTEIN REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K845052	PARAMAX TOTAL PROTEIN REAGENT TP	Apr 13, 1984	Substantially Equivalent	American Dade
K840290	MCS TOTAL PROTEIN REAGENT	Mar 30, 1984	Substantially Equivalent	Medilab Corp.
K833950	TOTAL PROTEIN REAGENT CS-724	Jan 13, 1984	Substantially Equivalent	Fisher Scientific Co., LLC
K832169	TOTAL PROTEIN PROCEDURE	Aug 16, 1983	Substantially Equivalent	Sandare Chemical Co., Inc.
K830538	FLOW-PAC TOTAL PROTEIN REAGENT SET	Mar 24, 1983	Substantially Equivalent	Amresco, Inc.
K823579	COBAS REAGENT FOR TOTAL PROTEIN	Jan 07, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K823170	LIQUIZYME TOTAL PROTEIN REAGENT	Nov 29, 1982	Substantially Equivalent	Amresco, Inc.
K822468	PSI TOTAL PROTEIN REAGENT	Sep 14, 1982	Substantially Equivalent	Pointe Scientific, Inc.,
K821905	BIURET (COLORIMETRIC) TOTAL PROTEIN	Jul 20, 1982	Substantially Equivalent	American Monitor Corp.
K821210	SERUM TOTAL PROTEIN REAGENT SET	Jul 13, 1982	Substantially Equivalent	Omega Medical Electronics
K820913	RA-1000 SYSTEM ADD'L ANALYTES PHASE III	May 03, 1982	Substantially Equivalent	Technicon Instruments Corp.
K813536	ASTRA TOTAL PROTEIN REAGENT	Dec 31, 1981	Substantially Equivalent	Hi Chem, Inc.
K812833	TOTAL PROTEIN REAGENT SET	Nov 27, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K813038	ULTRACHEM TP, ITEM #64974	Nov 10, 1981	Substantially Equivalent	Harleco
K812028	KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)	Aug 03, 1981	Substantially Equivalent	Eastman Kodak Company
K811673	TOTAL PROTEIN TEST	Jun 25, 1981	Substantially Equivalent	King Diagnostics, Inc.
K802310	IL TOTAL PROTEIN REAGENT	Oct 23, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K802161	BIURET REAGENT & TOTAL PROTEIN BLANK SOL	Oct 10, 1980	Substantially Equivalent	Panmed, Inc.
K801749	BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM	Sep 16, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K801061	TOTAL PROTEIN TEST	Jul 21, 1980	Substantially Equivalent	Environmental Chemical Specialties
K800674	SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K792346	TWO MINUTE PROTEINTEST	Dec 06, 1979	Substantially Equivalent	Panmed, Inc.
K792340	CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE	Dec 06, 1979	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K792138	SMAC (SEQUENTIAL MULT. ANALYSIS COMP.	Nov 13, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K790808	PROTEIN ASSAY KIT	Nov 05, 1979	Substantially Equivalent	Specialty Medical Industries, Inc.
K781897	STAT KIT, MICROPROTEIN	Jan 10, 1979	Substantially Equivalent	Pierce Chemical Co.
K781774	TOTAL PROTEIN	Nov 22, 1978	Substantially Equivalent	Gilford Diagnostics
K781722	REAGENT SET, TOTAL PROTEIN	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K772155	ULTRACHEM TOTAL PROTEIN, #64974	Dec 06, 1977	Substantially Equivalent	Harleco
K771926	TOTAL PROTEIN SET, ITEM NO. 64010	Nov 11, 1977	Substantially Equivalent	Harleco
K771841	TOTAL PROTEIN	Oct 25, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K771476	MULTISTAT III TOTAL PROTEIN TEST	Sep 12, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770887	AUTO TOTAL PROTEIN FOR ANALYZER	Jul 14, 1977	Substantially Equivalent	Harleco
K770452	PROTEIN PROCEDURE, TEKPOINT TOTAL	May 03, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K761257	AUTO TOTAL PROTEIN	Dec 21, 1976	Substantially Equivalent	Harleco
K761217	AUTO TOTAL PROTEIN	Dec 21, 1976	Substantially Equivalent	Harleco
K760480	REAGENT, TOTAL PROTEIN DETERMINATION	Oct 29, 1976	Substantially Equivalent	Simmler & Son, Inc.