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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: CGZ FDA class 2

    Electrode, Ion-Specific, Chloride

    Clinical Chemistry

    View full classification →

    The Electrode, Ion-Specific, Chloride test system (product code CGZ) is an in-vitro diagnostic device used in clinical chemistry to measure chloride ion concentrations in serum, plasma, or urine using an ion-specific electrode, supporting the evaluation of electrolyte balance and acid-base disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1170 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
    Alinity c ICT Sample Diluent
    VITROS Chemistry Products Cl- Slides
    VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
    AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
    ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
    COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
    OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
    pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
    PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
    DELFIA NEONATAL IRT KIT, MODEL A005-110
    AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
    DELFIA NEONATAL IRT KIT
    EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
    ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    IRMA BLOOD ANALYSIS SYSTEM
    ILAB 600 CLINICAL CHEMISTRY SYSTEM
    AEROSET SYSTEM
    SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
    ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
    SYNERMED ISE REAGENTS
    CAPILLARY ADAPTOR ACCESSORY
    ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
    HICHEM ISEKCI SOLUTION KIT 70010
    HICHEM ISE DILUENT KIT 70008
    HICHEM ISE INTDERNAL REFERENCE KIT 70009
    MODEL 644 SWEAT DILUENT
    NOVA 13 ANALYZER, MODIFICATION
    NOVA 13 ANALYZER
    ISE/CI-
    ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
    OLYMPUS ISE MODULE FOR AU5000
    OLYMPUS ISE MODULE
    WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
    SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
    ION-SPECIFIC ELECTRODE, CHLORIDE
    ISE REAGENTS FOR DEMAND ANALYZER
    NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER

    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.

    Popular Product Codes

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