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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: JFY FDA class 2

    Enzymatic Method, Creatinine

    Clinical Chemistry

    View full classification →

    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.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Atellica CH Enzymatic Creatinine_3 (ECre3)
    Yumizen C1200 Creatinine PAP
    ACR LAB Urine Analysis Test System
    GEM Premier ChemSTAT
    URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
    VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
    Teco Creatinine Enzymatic Reagent Kit
    URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
    Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
    ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
    ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
    ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
    SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
    SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
    DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
    S-TEST CREATININE (CRE)
    MULTIGENT CREATININE (ENZYMATIC) ASSAY
    AFINION ACR AND ACR CONTROL
    DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
    CREATININE (ENZYMATIC)
    ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    ENZYMATIC CREATININE ASSAY (265 SERIES)
    VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
    VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
    DIAZYME CREATININE LIQUID REAGENTS ASSAY
    THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
    WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
    VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
    POLY-CHEM CREATININE
    CREATININE LIQUICOLOR
    IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
    COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
    CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
    WIENER LAB. CREATININA CINETICA AA
    BIOSCANNER CREATININE TEST STRIPS
    CREATININE PLUS
    VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
    DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
    CARESIDE CREATININE
    ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
    REFLOTRON CREATININE TEST TABS
    REFLOTRON CREATININE TEST TABS
    KODAK EKTACHEM DT SLIDES (CRSC)
    RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
    CREATININE-E
    CREATININE PAP
    CREATININE REAGENT SET
    ENXYMATIC CREATININE TEST

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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