BEUDAMED
    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: CFR FDA class 2

    Hexokinase, Glucose

    Clinical Chemistry

    View full classification →

    The Hexokinase, Glucose test system (product code CFR) is an in-vitro diagnostic device used in clinical chemistry to measure glucose concentrations in biological specimens using the hexokinase enzymatic method, which is a widely accepted reference technique for glucose quantification. It is classified as FDA Class 2, indicating 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
    cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
    Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
    ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
    ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
    Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
    UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
    ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
    ADVIA CHEMISTRY GLUH_3 REAGENTS
    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
    BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
    LIASYS 450
    PRESTIGE 24I; BIOLIS 24I; MGC 240
    PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
    ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
    COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
    POLY-CHEM 90 GLUCOSE
    EASYRA GLU-H REAGENT, MODEL 10200
    ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
    LIASYS WITH MODELS LIASYS
    APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
    S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
    BS-200 CHEMISTRY ANALYZER, MODE BS-200
    POINTE 360
    SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
    GLUCOSE HK NEW FORMULATION TEST SYSTEM
    COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
    GLUCOSE
    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
    ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
    ADVIA IMS GLUCOSE ASSAY
    DATAPRO CLINICAL CHELISTRY ANALYZER
    RAICHEM GLUCOSE UV (LIQUID)
    GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
    WAKO L-TYPE GLUCOSE 2
    GLUCOSE-SL-C ASSAY, MODEL 257-30
    POLY-CHEM GLUCOSE
    ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
    RAICHEM GLUCOSE UV REAGENT
    GLUCOSE (HEXOKINASE)
    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
    SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
    ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
    GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
    GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
    INFINITY GLUCOSE REAGENT
    N-ASSAY GLU-UL
    GLU
    GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    GLUCOSE REAGENT
    LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    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