Clinical Chemistry

JFY · Enzymatic Method, Creatinine

Clinical Chemistry · 21 CFR 862.1225 · Class 2

Overview

Product CodeJFY
Device NameEnzymatic Method, Creatinine
Regulation21 CFR 862.1225
Device ClassClass 2
Review PanelClinical Chemistry
3rd-Party ReviewableYes

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Classification Rationale

Class II.

Cleared Devices (49)

RecordDevice NameApplicantDecision DateDecision
K252619QSCHECK UISACRQstag, Inc.Feb 20, 2026SESE
K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.Nov 24, 2021SESE
K193649Yumizen C1200 Creatinine PAPHORIBA ABX SASMay 10, 2021SESE
K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.Jul 26, 2019SESE
K183555GEM Premier ChemSTATInstrumentation Laboratory COFeb 16, 2019SESE
K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics CorporationDec 10, 2018SESE
K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.Oct 30, 2018SESE
K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc.Jul 21, 2017SESE
K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTeco Diagnostics, Inc.Mar 7, 2016SESE
K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )ACON Laboratories, Inc.Dec 22, 2014SESE
K132399ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELElitechgroupJan 3, 2014SESE
K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CLSeppim S.A.S.Nov 18, 2011SESE
K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINHORIBA ABX SASAug 10, 2011SESE
K093458SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298Beckman Coulter, Inc.Dec 4, 2009SESE
K091742SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298Beckman Coulter, Inc.Aug 14, 2009SESE
K090330DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270Siemens Healthcare Diagnostics, Inc.May 22, 2009SESE
K080073S-TEST CREATININE (CRE)Alfa Wassermann, Inc.Jun 30, 2008SESE
K073634MULTIGENT CREATININE (ENZYMATIC) ASSAYSENTINEL CH. SpAJun 19, 2008SESE
K072409AFINION ACR AND ACR CONTROLAxis-Shield Poc ASFeb 12, 2008SESE
K073055DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270Dade Behring, Inc.Jan 3, 2008SESE
K070824CREATININE (ENZYMATIC)Thermofisher Scientific OYDec 3, 2007SESE
K070727ADVIA CHEMISTRY ENZYMATIC CREATININE_2Siemens Medical Solutions DiagnosticsAug 3, 2007SESE
K070383ENZYMATIC CREATININE ASSAY (265 SERIES)Diagnostic Chemicals , Ltd.Jun 22, 2007SESE
K071216VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927Ortho-Clinical Diagnostics, Inc.May 25, 2007SESE
K071215VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927Ortho-Clinical Diagnostics, Inc.May 25, 2007SESE
K062105DIAZYME CREATININE LIQUID REAGENTS ASSAYDiazyme LaboratoriesApr 23, 2007SESE
K061412THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401Thermo Electron Corp.Mar 23, 2007SESE
K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORWako Chemicals USA, Inc.Feb 23, 2007SESE
K063591VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208Ortho-Clinical Diagnostics, Inc.Dec 15, 2006SESE
K061944POLY-CHEM CREATININEPolymedco, Inc.Nov 3, 2006SESE
K050283CREATININE LIQUICOLORStanbio LaboratoryJun 30, 2005SESE
K030035IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGEDiametrics Medical, Inc.Jun 25, 2003SESE
K024098COBAS INTEGRA CREATININE PLUS VER.2 ASSAYRoche Diagnostics Corp.Dec 19, 2002SESE
K021428CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEMBayer Corp.Jul 5, 2002SESE
K012065WIENER LAB. CREATININA CINETICA AAWiener Laboratories SaicOct 10, 2001SESE
K010456BIOSCANNER CREATININE TEST STRIPSPolymer Technology Systems, Inc.Jun 20, 2001SESE
K003261CREATININE PLUSRoche Diagnostics Corp.Nov 16, 2000SESE
K001310VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1Ortho-Clinical Diagnostics, Inc.May 5, 2000SESE
K984530DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSEMetrika, Inc.Aug 10, 1999SESE
K980043CARESIDE CREATININEExigent Diagnostics, Inc.Mar 30, 1998SESE
K912807ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17Em Diagnostic Systems, Inc.Oct 31, 1991SESE
K913105REFLOTRON CREATININE TEST TABSBoehringer Mannheim Corp.Aug 12, 1991SESE
K903573REFLOTRON CREATININE TEST TABSBoehringer Mannheim Corp.Sep 7, 1990SESE
K875191KODAK EKTACHEM DT SLIDES (CRSC)Eastman Kodak CompanyFeb 24, 1988SESE
K864992RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)Reagents Applications, Inc.Feb 12, 1987SESE
K863078CREATININE-EJ. D. Assoc.Sep 9, 1986SESE
K854766CREATININE PAPBoehringer Mannheim Corp.Jan 17, 1986SESE
K841070CREATININE REAGENT SETMedical Specialties, Inc.May 1, 1984SESE
K812095ENXYMATIC CREATININE TESTBoehringer Mannheim Corp.Aug 31, 1981SESE

Top Applicants

Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from the tree

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...