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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: LFR FDA class 2

    Glucose Dehydrogenase, Glucose

    Clinical Chemistry

    View full classification →

    A glucose dehydrogenase-based glucose test is a clinical chemistry laboratory device that uses the glucose dehydrogenase enzyme reaction to measure glucose concentrations in blood or other biological specimens, used in the diagnosis and monitoring of diabetes and hypoglycemia. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LFR and is regulated under 21 CFR 862.1345 within the Clinical Chemistry specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FreeStyle InsuLinx Blood Glucose Monotioring System
    ACCU-CHEK AVIVA EXPERT SYSTEM
    EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
    CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
    ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
    NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
    GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
    NOVA ONE BLOOD GLUCOSE MONITOR
    PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
    GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
    GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
    CONTOUR NEXT BLOOD GLUCOSE METER
    TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
    EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
    U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
    CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
    CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
    EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
    CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
    FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
    EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
    ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
    EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
    ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
    FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
    EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
    RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
    THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
    HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
    MODIFICATION TO ACCU-CHEK GO SYSTEM
    ACCU-CHEK INTEGRA SYSTEM
    ACCU-CHEK AVIVA SYSTEM
    CLINICAL LABORATORY ANALYZING SYSTEM
    ACCU-CHEK GO SYSTEM
    SENOVA(R) BLOOD GLUCOSE MONITOR
    ACCU-CHEK COMPACT TEST STRIP
    MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
    PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
    ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
    ACCU-CHEK INFORM METER
    ACCU-CHEK COMFORT CURVE TEST STRIP
    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
    SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
    CONNECT DATA MANAGEMENT SYSTEM
    ACCU-CHEK COMPLETE METER
    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
    ACCU-CHEK SIMPLICITY SYSTEM
    ACCU-CHEK HQ SYSTEM
    ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
    ACCU-CHEK COMFORT CURVE TEST STRIP

    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