Product Code: JFY FDA class 2 21 CFR 862.1225

Enzymatic Method, Creatinine

Clinical Chemistry

Enzymatic Method for Creatinine is a clinical chemistry test system that uses enzymatic reactions to measure creatinine concentration in serum, plasma, or urine, providing a widely used indicator of kidney function and glomerular filtration rate. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JFY, regulated under 21 CFR 862.1225, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JFY
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252619	QSCHECK UISACR	Feb 20, 2026	Substantially Equivalent	Qstag, Inc.
K212223	Atellica CH Enzymatic Creatinine_3 (ECre3)	Nov 24, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K193649	Yumizen C1200 Creatinine PAP	May 10, 2021	Substantially Equivalent	HORIBA ABX SAS
K182384	ACR LAB Urine Analysis Test System	Jul 26, 2019	Substantially Equivalent	Healthy.Io, Ltd.
K183555	GEM Premier ChemSTAT	Feb 16, 2019	Substantially Equivalent	Instrumentation Laboratory CO
K182038	URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer	Dec 10, 2018	Substantially Equivalent	Yd Diagnostics Corporation
K182063	VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System	Oct 30, 2018	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K161527	Teco Creatinine Enzymatic Reagent Kit	Jul 21, 2017	Substantially Equivalent	Teco Diagnostics, Inc.
K152835	URITEK TC-201 URINE CHEMISTRY TEST SYSTEM	Mar 07, 2016	Substantially Equivalent	Teco Diagnostics, Inc.
K142391	Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )	Dec 22, 2014	Substantially Equivalent	ACON Laboratories, Inc.
K132399	ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL	Jan 03, 2014	Substantially Equivalent	Elitechgroup
K103376	ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL	Nov 18, 2011	Substantially Equivalent	Seppim S.A.S.
K110137	ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN	Aug 10, 2011	Substantially Equivalent	HORIBA ABX SAS
K093458	SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298	Dec 04, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K091742	SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298	Aug 14, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K090330	DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270	May 22, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K080073	S-TEST CREATININE (CRE)	Jun 30, 2008	Substantially Equivalent	Alfa Wassermann, Inc.
K073634	MULTIGENT CREATININE (ENZYMATIC) ASSAY	Jun 19, 2008	Substantially Equivalent	SENTINEL CH. SpA
K072409	AFINION ACR AND ACR CONTROL	Feb 12, 2008	Substantially Equivalent	Axis-Shield Poc AS
K073055	DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270	Jan 03, 2008	Substantially Equivalent	Dade Behring, Inc.
K070824	CREATININE (ENZYMATIC)	Dec 03, 2007	Substantially Equivalent	Thermofisher Scientific OY
K070727	ADVIA CHEMISTRY ENZYMATIC CREATININE_2	Aug 03, 2007	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K070383	ENZYMATIC CREATININE ASSAY (265 SERIES)	Jun 22, 2007	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K071216	VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927	May 25, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K071215	VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927	May 25, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K062105	DIAZYME CREATININE LIQUID REAGENTS ASSAY	Apr 23, 2007	Substantially Equivalent	Diazyme Laboratories
K061412	THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401	Mar 23, 2007	Substantially Equivalent	Thermo Electron Corp.
K061775	WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR	Feb 23, 2007	Substantially Equivalent	Wako Chemicals USA, Inc.
K063591	VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208	Dec 15, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K061944	POLY-CHEM CREATININE	Nov 03, 2006	Substantially Equivalent	Polymedco, Inc.
K050283	CREATININE LIQUICOLOR	Jun 30, 2005	Substantially Equivalent	Stanbio Laboratory
K030035	IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE	Jun 25, 2003	Substantially Equivalent	Diametrics Medical, Inc.
K024098	COBAS INTEGRA CREATININE PLUS VER.2 ASSAY	Dec 19, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K021428	CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM	Jul 05, 2002	Substantially Equivalent	Bayer Corp.
K012065	WIENER LAB. CREATININA CINETICA AA	Oct 10, 2001	Substantially Equivalent	Wiener Laboratories Saic
K010456	BIOSCANNER CREATININE TEST STRIPS	Jun 20, 2001	Substantially Equivalent	Polymer Technology Systems, Inc.
K003261	CREATININE PLUS	Nov 16, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001310	VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	May 05, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K984530	DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE	Aug 10, 1999	Substantially Equivalent	Metrika, Inc.
K980043	CARESIDE CREATININE	Mar 30, 1998	Substantially Equivalent	Exigent Diagnostics, Inc.
K912807	ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17	Oct 31, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K913105	REFLOTRON CREATININE TEST TABS	Aug 12, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K903573	REFLOTRON CREATININE TEST TABS	Sep 07, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K875191	KODAK EKTACHEM DT SLIDES (CRSC)	Feb 24, 1988	Substantially Equivalent	Eastman Kodak Company
K864992	RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)	Feb 12, 1987	Substantially Equivalent	Reagents Applications, Inc.
K863078	CREATININE-E	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K854766	CREATININE PAP	Jan 17, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K841070	CREATININE REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K812095	ENXYMATIC CREATININE TEST	Aug 31, 1981	Substantially Equivalent	Boehringer Mannheim Corp.