Product Code: CGX FDA class 2 21 CFR 862.1225

Alkaline Picrate, Colorimetry, Creatinine

Clinical Chemistry

The Alkaline Picrate, Colorimetry, Creatinine test system (product code CGX) is an in-vitro diagnostic device used in clinical chemistry to measure creatinine in serum or urine using the Jaffe alkaline picrate colorimetric method, a long-established technique for kidney function assessment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1225 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

159

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CGX
Device Class: FDA class 2
Regulation Number: 862.1225
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 159 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252206	Nova Allegro UACR Assay, Nova Allegro Analyzer	Jan 09, 2026	Substantially Equivalent	Nova Biomedical Corporation
K251058	Tru Kidney Health Test Panel; Tru Analyzer	Nov 26, 2025	Substantially Equivalent	Truvian Health
K242685	Atellica® CH Creatinine_3 (Crea3)	Dec 04, 2024	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K221813	Nova Allegro UACR Assay, Nova Allegro Analyzer	Nov 19, 2024	Substantially Equivalent	Nova Biomedical Corporation
K210452	Creatinine2	Mar 22, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K161494	Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)	Nov 15, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K132638	DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE	Jan 27, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133728	DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE	Jan 24, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K123586	EASYRA CREATININE REAGENT	May 15, 2013	Substantially Equivalent	Medica Corporation
K110530	ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL	Apr 30, 2012	Substantially Equivalent	HORIBA ABX SAS
K083809	CREATININE	Apr 07, 2009	Substantially Equivalent	Abbott Laboratories
K072115	ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H	Nov 30, 2007	Substantially Equivalent	Horiba Abx
K071283	SYNCHRON SYSTEMS CREATININE REAGENT	Jun 01, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K071280	SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS	Jun 01, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K071277	SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS	Jun 01, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K061193	CREATININE	Jun 23, 2006	Substantially Equivalent	Abbott Laboratories, Inc.
K060935	SYNCHRON SYSTEMS CREATININE (CREA) REAGENT	Apr 28, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K050652	SPOTCHEM II CREATININE, AMYLASE & ALP TESTS	Apr 06, 2005	Substantially Equivalent	Arkray, Inc.
K040976	GENCHEM CREATININE REAGENT	Dec 27, 2004	Substantially Equivalent	Genchem, Inc.
K033058	CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS	Jan 30, 2004	Substantially Equivalent	Diamond Diagnostics, Inc.
K023407	ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR	Feb 14, 2003	Substantially Equivalent	Elan Diagnostics
K002156	APPRAISE URINE MICROALBUMIN COLLECTION KIT	Dec 19, 2000	Substantially Equivalent	Osborn Group, Inc.
K003247	CREATININE	Dec 14, 2000	Substantially Equivalent	Jas Diagnostics, Inc.
K001769	VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT	Jun 21, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics
K000055	CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17	Feb 18, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K991109	CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02	May 25, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K983937	DUAL VIAL CREATININE REAGENT	Jan 06, 1999	Substantially Equivalent	Intersect Systems, Inc.
K981799	CREA	Jul 22, 1998	Substantially Equivalent	Abbott Laboratories
K981240	CREATININE (CREA)	May 29, 1998	Substantially Equivalent	Abbott Laboratories
K973993	RANDOX CREATININE	Mar 06, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K974909	SYNERMED CREATININE REAGENT KIT	Feb 24, 1998	Substantially Equivalent	Synermed Intl., Inc.
K972743	SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT	Sep 22, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K971908	CREA OR CREATININE	Jun 17, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K970087	CR PERFECT	Mar 06, 1997	Substantially Equivalent	Chimera Research & Chemical, Inc.
K963534	SIGMA DIAGNOSTICS CREATININE REAGENT KIT	Sep 30, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K955938	CREATININE REAGENT	Mar 12, 1996	Substantially Equivalent	Derma Media Lab., Inc.
K954266	STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY	Oct 13, 1995	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K951595	ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES	Sep 08, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K950142	CR PERFECT	May 25, 1995	Substantially Equivalent	Chimera Research & Chemical, Inc.
K945655	CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)	Jan 05, 1995	Substantially Equivalent	Miles, Inc.
K943005	CREATININE QVET	Nov 22, 1994	Substantially Equivalent	Prisma Systems
K943924	CREATININE-PO REAGENT KIT	Sep 20, 1994	Substantially Equivalent	Synermed, Inc.
K941837	ROCHE REAGENT FOR CREATININE	Aug 26, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934071	KODAK EKTACHEM DT SLIDES (URCR)	Mar 21, 1994	Substantially Equivalent	Eastman Kodak Company
K934587	CREATININE-S ASSAY	Mar 11, 1994	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K934361	OLYMPUS CREATININE REAGENT	Nov 16, 1993	Substantially Equivalent	Olympus Corp.
K933697	SIGMA CRE REAGENT	Oct 18, 1993	Substantially Equivalent	Sigma Chemical Co.
K931939	OLYMPUS CREATININE REAGENT	Sep 21, 1993	Substantially Equivalent	Olympus Corp.
K932160	SYSTEMATE CREATININE TEST ITEM NUMBER 65413	Jul 09, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K926511	SYNERMED SINGLE REAGENT CREATININE KIT	Feb 18, 1993	Substantially Equivalent	Synermed, Inc.
K925668	CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM	Dec 28, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K924692	OLYMPUS CREATININE REAGENT	Oct 19, 1992	Substantially Equivalent	Olympus Corp.
K924599	CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2	Oct 15, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923526	OLYMPUS CREATININE REAGENT	Sep 18, 1992	Substantially Equivalent	Olympus Corp.
K923203	SYSTEMATE CREATININE TEST	Sep 09, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923039	MILES URINE CREATININE METHOD	Aug 24, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K915077	SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,	Dec 18, 1991	Substantially Equivalent	Beckman Instruments, Inc.
K913707	ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28	Sep 18, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905658	SYSTEMATE CREATININE (EPOS APPLICATION) #65413	May 08, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K910147	CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED	Mar 11, 1991	Substantially Equivalent	Olympus Corp.
K905619	CREATININE (RATE) REAGENT SET	Feb 13, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K893582	N-A-G TEST KIT	Oct 01, 1990	Substantially Equivalent	Ppr Diagnostics , Ltd.
K902561	ROCHE COBAS READY CREATININE REAGENT	Sep 07, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K903296	SYNERMED CREATININE REAGENT KIT	Aug 17, 1990	Substantially Equivalent	Synermed, Inc.
K902172	COULTER CREATININE REAGENT	Jun 28, 1990	Substantially Equivalent	Coulter Corp.
K901229	CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)	May 04, 1990	Substantially Equivalent	Technicon Instruments Corp.
K901298	CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY	Apr 25, 1990	Substantially Equivalent	Olympus Corp.
K900666	AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791	Apr 19, 1990	Substantially Equivalent	American Research Products Co.
K896686	AMRESCO CREATININE REAGENT #4316100	Feb 08, 1990	Substantially Equivalent	American Research Products Co.
K895847	CREATININE 340 (ENZYMATIC)	Oct 30, 1989	Substantially Equivalent	Sclavo, Inc.
K895022	SYSTEMATE CREATININE TEST (CREA) #65413	Oct 23, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890671	HI CHEM CREATININE REAGENT (PRODUCT #88809)	May 09, 1989	Substantially Equivalent	Hichem Diagnostics
K884734	CREATININE TEST (CREA) ITEM #65663	Dec 19, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K881856	BIOTROL CREATININE H.P. REAGENT	Jun 16, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K881400	CREATININE FOR CONTINUOUS FLOW INSTRUMENTS	Apr 28, 1988	Substantially Equivalent	Catachem, Inc.
K880843	CREATININE REAGENT SET (KINETIC)	Apr 05, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K880629	CREATININE	Mar 23, 1988	Substantially Equivalent	Tech-Co, Inc.
K873531	PARAMAX CREATININE REAGENT	Nov 23, 1987	Substantially Equivalent	Baxter Healthcare Corp
K874088	EASY-TEST CREATININE (CREA) ITEM NO. 19009	Nov 06, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K873131	CREATININE REAGENT KIT	Oct 23, 1987	Substantially Equivalent	A-Kem, Inc.
K873725	MULTICHEM CREATININE REAGENT S0917	Oct 20, 1987	Substantially Equivalent	Simmler, Inc.
K873365	CREATININE REAGENT	Oct 02, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K873310	ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT	Sep 02, 1987	Substantially Equivalent	Abbott Laboratories
K872310	CURAD MEDICATED PLASTIC STRIPS	Aug 28, 1987	Substantially Equivalent	The Kendal Co.
K870366	CREATININE REAGENT - PICRIC ACID METHOD	Aug 19, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K863079	CREATINKINETIC	Dec 12, 1986	Substantially Equivalent	J. D. Assoc.
K863738	EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95	Nov 05, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863261	CREATININE PROCEDURE	Oct 02, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861655	CREATININE PROCEDURE	Jul 01, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861819	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)	Jun 11, 1986	Substantially Equivalent	Eastman Kodak Company
K860418	CREATININE REAGENT SET	Feb 11, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855193	CREATININE REAGENT SET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K854846	VISION CREATININE	Jan 13, 1986	Substantially Equivalent	Abbott Laboratories
K854178	IN-VITRO TEST FOR THE DETERMINATION OF CREATININE	Nov 25, 1985	Substantially Equivalent	Clinical Data, Inc.
K853888	AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &	Oct 15, 1985	Substantially Equivalent	American Research Products Co.
K852565	TECHNICON CHEMI	Jul 12, 1985	Substantially Equivalent	Technicon Instruments Corp.
K850932	CREATININE	Jun 25, 1985	Substantially Equivalent	Dilab, Inc.
K851993	CRE BUFFER CRE DYE	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K851849	CREATINE LIQUID STABLE REAGENT SET	May 20, 1985	Substantially Equivalent	Medical Analysis Systems, Inc.
K844332	CREATININE REAGENT FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K844024	CREATININE REAGENT SET	Oct 30, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843916	TDX REA CREATININE	Oct 30, 1984	Substantially Equivalent	Abbott Laboratories
K843377	CREATININE ASSAY KIT	Sep 28, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K843179	CREATININE TEST	Sep 07, 1984	Substantially Equivalent	Sclavo, Inc.
K843105	SYSTEMATE CREATININE 67223	Aug 27, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842159	CREATININE ASSAY KIT-KINETIC OR ENDPOINT	Aug 16, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841377	CREATININE - A.A.S.	May 11, 1984	Substantially Equivalent	Advanced Analytical Systems, Inc.
K840872	RAICHEM CREATININE REAGENT	Apr 18, 1984	Substantially Equivalent	Reagents Applications, Inc.
K832439	CREATININE REAGENT SET	Jan 17, 1984	Substantially Equivalent	Amresco, Inc.
K831628	CREATININE REAGENTS B6370-13	Jul 06, 1983	Substantially Equivalent	American Scientific Products
K831627	CREATININE REAGENTS B6360-10	Jul 06, 1983	Substantially Equivalent	American Scientific Products
K830556	CREATININE	Mar 24, 1983	Substantially Equivalent	Pointe Scientific, Inc.,
K830537	FLOW-PAC CREATININE REAGENT SET	Mar 24, 1983	Substantially Equivalent	Amresco, Inc.
K830447	KINETIC CREATININE	Mar 24, 1983	Substantially Equivalent	American Monitor Corp.
K823806	DIRECT CREATININE PROCEDURE	Jan 14, 1983	Substantially Equivalent	Analytical & Research Chemicals, Inc.
K823573	COBAS REAGENT FOR CREATININE	Jan 07, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K823572	COBAS STANDARDS FOR CREATININE	Jan 07, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K822118	FERMCOTEST CREATININE TEST REAGENT	Sep 30, 1982	Substantially Equivalent	Fermco Biochemics, Inc.
K821881	ULTRACHEM CREA	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K821199	CREATININE REAGENT SET	Jul 13, 1982	Substantially Equivalent	Omega Medical Electronics
K813560	LIQUIZYME CREATININE REAGENT SET	Jan 29, 1982	Substantially Equivalent	Amresco, Inc.
K820075	SERALYZER CREATININE REAGENT STRIPS	Jan 26, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K812834	CREATININE REAGENT SET	Dec 03, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K813043	ULTRACHEM CREA ITEM #64972	Nov 10, 1981	Substantially Equivalent	Harleco
K812109	GILCHEM CREATININE REAGENT	Aug 13, 1981	Substantially Equivalent	Gilford Diagnostics
K811406	CREATININE RATE REAGENT KIT	Aug 13, 1981	Substantially Equivalent	Chem-Elec, Inc.
K811659	CREATININE REAGENT	Jun 26, 1981	Substantially Equivalent	Gilford Diagnostics
K811664	CREATININE TEST	Jun 25, 1981	Substantially Equivalent	King Diagnostics, Inc.
K803087	LANCER CREATININE MICROSAMPLE STAT ANA	Jan 02, 1981	Substantially Equivalent	Sherwood Medical Co.
K802156	REAGENTS SERUM CREATINE USING TECHICON	Oct 10, 1980	Substantially Equivalent	Panmed, Inc.
K800685	REAGENT FOR DETERM. CREATININE IN H/SERU	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K800583	NSI CREATININE KIT	Apr 02, 1980	Substantially Equivalent	Nobel Scientific Industries, Inc.
K800219	SERUM CREATININE; ALK. BUFFER & PICRIC	Feb 26, 1980	Substantially Equivalent	Fisher Scientific Co., LLC
K792404	ELVI CREATININE	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792402	ELVI CREATININ	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792397	ELVI CREATININE	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K791994	CREATININE DIAG. REAGENT PICRIC ACID	Oct 17, 1979	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K791689	PICRIC SOLUTION	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K791688	ALKALINE BUFFER	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K790044	REAGENT KIT, BAKERS DIAGNOSTIC	Feb 22, 1979	Substantially Equivalent	J.T. Baker Chemical Co.
K782094	HILAR	Jan 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K781884	SERUM, CREATININE DETERMINATIONS	Dec 20, 1978	Substantially Equivalent	Fisher Scientific Co., LLC
K781396	CREATININE REAGENT SET	Sep 14, 1978	Substantially Equivalent	Nobel Scientific Industries, Inc.
K780514	ULTRACHEM CREATININE 64972, CENTRIFUCHEM	May 19, 1978	Substantially Equivalent	Harleco
K772157	CREATININE, 64972	Dec 06, 1977	Substantially Equivalent	Harleco
K772107	CREATININE URINE APPLI.-#32308	Nov 28, 1977	Substantially Equivalent	Harleco
K771856	DIR. QUANT. COLOR. DETERM. SERUM CREAT.	Nov 03, 1977	Substantially Equivalent	Stanbio Laboratory
K771834	CREATININE	Nov 03, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K771916	PROCEDURE NO. 555	Oct 19, 1977	Substantially Equivalent	Sigma Chemical Co.
K771773	CLINICARD CREATININE CHEMISTRY	Oct 14, 1977	Substantially Equivalent	Harleco
K771443	MULTISTAT III CREATININE TEST	Aug 22, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K771365	CREATININE ANALYSIS PRODUCTS	Aug 16, 1977	Substantially Equivalent	Abbott Laboratories
K771335	CREATININE ANALYZER 2	Aug 03, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K770819	ULTRACHEM CREATININE	Jul 11, 1977	Substantially Equivalent	Harleco
K770643	CREATININE TEST, SUPER SEVENTEEN	Jun 24, 1977	Substantially Equivalent	Hycel, Inc.
K770454	CREATININE PROCEDURE, TEKPOINT	May 03, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K770242	REAGENT SYSTEM	Feb 22, 1977	Substantially Equivalent	American Monitor Corp.
K761280	AUTO CREATININE REAGENT (GILFORD 3400-E)	Feb 14, 1977	Substantially Equivalent	Harleco
K761279	AUTO CREATININE REAGENT (ABBOTT SYSTEM)	Feb 11, 1977	Substantially Equivalent	Harleco