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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: CGA FDA class 2

    Glucose Oxidase, Glucose

    Clinical Chemistry

    View full classification →

    The Glucose Oxidase, Glucose test system (product code CGA) is an in-vitro diagnostic device used in clinical chemistry to measure glucose levels in biological fluids using the glucose oxidase enzymatic reaction, a widely used method for blood glucose determination. It is classified as FDA Class 2, representing moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1345 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    YSI 2900C Biochemistry Analyzer
    EasyStat 300
    Cholestech LDX ™ System
    i-STAT G cartridge with the i-STAT 1 System
    i-STAT CG8+ cartridge with the i-STAT 1 System
    GEM Premier ChemSTAT
    Nova Primary Glucose Analyzer System
    i-STAT CHEM8+ cartridge with the i-STAT 1 System
    Stat Profile Prime Plus Analyzer System
    i-STAT CHEM8+ cartridge with the i-STAT 1 System
    VITROS XT Chemistry Products GLU-Ca Slides
    GEM Premier ChemSTAT
    PTS Professional Chemistry Kit
    Stat Profile Prime Plus Analyzer System
    VITROS Chemistry Products GLU Slides
    i-Stat Alinity System with i-Stat Glucose test
    CardioChek Plus Test System, CardioChek Home Test System
    GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
    GEM Premier 3000
    Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
    ABL80 FLEX and ABL80 FLEX CO-OX
    GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
    CardioChek Plus Test System
    MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
    BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
    GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
    IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
    ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
    AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
    ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
    BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
    FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
    ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
    AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
    CLEVER CHOICE
    CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
    ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
    MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
    GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
    GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
    ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
    GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
    ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
    EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
    MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
    UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
    IVD-GE02
    I-STAT 1 WIRELESS 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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump