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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: NBW FDA class 2

    System, Test, Blood Glucose, Over The Counter

    Clinical Chemistry

    View full classification →

    The Over-The-Counter Blood Glucose Test System is a consumer-use in vitro diagnostic device that allows patients with diabetes to self-monitor blood glucose levels at home using a glucose meter and compatible test strips. Accurate blood glucose monitoring is essential for the management of diabetes mellitus. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1345 (Clinical Chemistry specialty).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TeleRPM Gen2 Blood Glucose Monitoring System
    RIGHTEST Blood Glucose Monitoring System Max Tel
    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
    VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
    WaveSense Jazz Blood Glucose Monitoring System
    CONTOUR® PLUS BLUE Blood Glucose Monitoring System
    RIGHTEST Blood Glucose Monitoring System Max Tel
    VivaChek Link Plus Blood Glucose Monitoring System
    TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System
    ReliOn Premier BLU Blood Glucose Monitoring System
    Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
    MIO Blood Glucose Monitoring System
    GlucoSure ADVANCE Link Blood Glucose Monitoring System
    CONTOUR® NEXT GEN Blood Glucose Monitoring System
    BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
    SuperCheck Pro Blood Glucose Monitoring System
    GlucoLeader Enhance 2 Blood Glucose Monitoring System
    GlucoSure Link Blood Glucose Monitoring System
    Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
    FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
    IWL2020 Blood Glucose Monitoring System
    MTM301 Blood Glucose and Ketone Monitoring System
    GAL-1A Plus Blood Glucose Monitoring System
    CardioChek Plus Test System; CardioChek Plus Home Test System
    Contour® next GEN Blood Glucose Monitoring System
    MultiSure GK Link Blood Glucose and Ketone Monitoring System
    CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
    GlucoSure HT Plus Blood Glucose Monitoring System
    EASYMAX Tag Self-Monitoring Blood Glucose System
    CONTOUR® NEXT ONE Blood Glucose Monitoring System
    Finetest Lite Blood Glucose Monitoring System
    Finetest Lite Smart Blood Glucose Monitoring System
    GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
    Livongo Blood Glucose Monitoring System (BG1000)
    Bioland Blood Glucose Monitoring System
    OneTouch Verio Reflect Blood Glucose Monitoring System
    CareSens S Clear BT Blood Glucose Monitoring System
    CareSens S Fit BT Blood Glucose Monitoring System
    ReliOn Premier Classic Blood Glucose Monitoring System
    CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
    MDT2 BLE Self-Monitoring Blood Glucose System
    On Call Express II Blood Glucose Monitoring System
    On Call Express Voice Blood Glucose Monitoring System
    TD-4183 Blood Glucose Monitoring System
    Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
    GlucoLeader Enhance Blood Glucose Monitoring System
    GLUCOCARD® W onyx Blood Glucose Monitoring System
    iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
    VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring 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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