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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: KHS FDA class 2

    Enzymatic, Carbon-Dioxide

    Clinical Chemistry

    View full classification →

    Enzymatic Carbon Dioxide is a clinical chemistry reagent system that uses enzymatic methods to measure total carbon dioxide or bicarbonate concentration in blood or serum, providing an assessment of the patient's acid-base status and electrolyte balance as part of a metabolic panel. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHS, regulated under 21 CFR 862.1160, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Carbon Dioxide Reagent Set
    Liquid CO2-2 (LCO2-2)
    S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
    AU BICARBONATE REAGENT
    ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
    VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
    ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
    ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
    EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
    ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
    VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
    SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
    S-TEST C02
    CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
    CARBON DIOXIDE LIQUID STABLE REAGENT
    DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
    DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
    CARBON DIOXIDE
    MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
    ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
    COBAS INTEGRA CARBON DIOXIDE ASSAY
    JAS CARBON DIOXIDE LIQUID REAGENT
    ANALYST PANELS + ANALYTICAL TEST ROTOR
    DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
    CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
    VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
    CARESIDE CO2, TOTAL
    CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
    CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
    CARBON DIOXIDE-SL ASSAY, CAT # 253-01
    RAICHEM CO2 REAGENT
    CO2
    COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
    CO2
    CARBON DIOXIDE - DST
    SYNERMED ENZYMATIC CO2 REAGENT KIT
    SERUM BICARBONATE/CARBON DIOXIDE
    TOTAL CO2
    CARBON DIOXIDE - DST
    CARBON DIOXIDE (C02)
    BOEHRINGER MANNHEIM BICARBONATE ASSAY
    TECHNISON AXON SYSTEM
    ENZYMATIC CO2 REAGENT, MODIFICATION
    BICARBONATE
    BICARBONATE
    SYNERMED ENZYMATIC CO2 REAGENT KIT
    COULTER CARBON DIOXIDE REAGENT
    ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
    SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
    TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD

    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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