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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: JJE FDA class 1

    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    Clinical Chemistry

    View full classification →

    This device is a photometric discrete chemistry analyzer used in clinical laboratories to perform automated spectrophotometric measurements of individual samples, enabling quantitative analysis of a wide range of biochemical analytes in patient specimens. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket submission. The product code is JJE, regulated under 21 CFR 862.2160, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
    CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
    XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
    RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
    DIMENSION EXL WITH LM SYSTEM
    ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
    DIMENSION CLINICAL CHEMISTRY SYSTEM
    INDIKO
    TC MATRIX CLINICAL CHEMISTRY ANALYZER
    VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
    DIMENSION VISTA INTEGRATED SYSTEM
    STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
    PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
    AUTOMATED WORKCELL CONTROL SOFTWARE
    MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
    OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
    BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
    ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
    ABBOTT AXSYM SYSTEM
    PERSONALLAB AUTOMATED MICROPLATE ANALYZER
    IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
    STRATEC LIA II ANALYZER
    SIGMA DIAGNOSTICS WASH CONCENTRATE
    COBAS CORE IMMUNOCHEMISTRY SYSTEM
    TECHNICON IMMUNO 1 SYSTEM
    OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
    VITROS SPECIALTY DILUENT
    ELECSYS 2010 ANALYZER
    BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
    SELECTA 20/60 CHEMISTRY ANALYZER
    SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
    ABBOTT PROJECT I, SPECTRUM
    ABBOTT AXSYM II SYSTEM
    SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
    ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
    TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
    MICROPLATE PROCESSOR 3000
    DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
    KODAK EKTACCHEM 950IRC ANALYZER
    PROCHEM CHEMISTRY ANALYZER
    DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
    HITACHI 914 ANALYZER
    AURAFLEX SYSTEMS
    ABBOTT PRISM ANALYZER
    CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
    SIGMA WASH CONCENTRATE SOLUTION
    ELS 1000
    ACE CLINICAL CHEMISTRY SYSTEM

    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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