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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: JGS FDA class 2

    Electrode, Ion Specific, Sodium

    Clinical Chemistry

    View full classification →

    An Ion-Specific Electrode for Sodium is a clinical chemistry device that uses selective ion electrodes to measure sodium ion concentration in blood or other biological specimens, essential for monitoring electrolyte balance, hydration status, and conditions such as hyponatremia and hypernatremia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JGS, regulated under 21 CFR 862.1665, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    i-STAT CG8+ cartridge with the i-STAT 1 System
    A-LYTE® Integrated Multisensor (IMT Na K Cl)
    ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
    GLP systems Track
    Stat Profile Prime Plus Analyzer System
    i-STAT CHEM8+ cartridge with the i-STAT 1 System
    Stat Profile Prime ES Comp Plus Analyzer System
    LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
    GEM Premier ChemSTAT
    Stat Profile Prime Plus Analyzer System
    Synermed ISE Reagents
    SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
    Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
    ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
    GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
    i-STAT Alinity System with i-STAT Sodium test
    BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
    Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
    ISE INDIRECT NA, K, C1 FOR GEN 2
    COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
    COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
    PROLYTE ELECTROLYTE ANALYZER
    ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
    EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
    PROLYTE ELECTROLYTE ANALYZER
    EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
    VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
    GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
    VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
    PROLYTE ELECTROLYTE ANALYZER
    EPOC BLOOD ANALYSIS SYSTEM
    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
    ISE INDIRECT NA, K, CL FOR GEN.2
    TECO ISE REAGENT SET FOR CX SYSTEM
    ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
    GENCHEM ELECTROLYTE BUFFER
    GENCHEM ISE ELECTROLYTE REFERENCE
    SYNCHRON LX I 725 CLINICAL SYSTEM
    PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
    MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
    EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
    BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
    STATLYTE NA/K/CL/LI ANALYZER
    I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
    STAT PROFILE PHOX PLUS ANALYZER
    HICHEM ISE ELECTROLYTE REFERENCE
    HICHEM ISE ELECTROLYTE BUFFER
    PICCOLO SODIUM TEST SYSTEM
    BAYER ADVIA 1650 CHEMISTRY SYSTEM
    CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000

    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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