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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: CDT FDA class 1

    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

    Clinical Chemistry

    View full classification →

    The Lipase Hydrolysis/Glycerol Kinase Enzyme Triglycerides Test is a clinical chemistry device that measures triglyceride concentrations in serum or plasma through a series of enzymatic reactions: lipase hydrolyzes triglycerides to glycerol, which is then phosphorylated by glycerol kinase and further oxidized, producing a measurable signal proportional to triglyceride content, used in lipid profiling and cardiovascular risk assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDT, regulated under 21 CFR 862.1705, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Triglycerides
    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
    VITROS CHEMISTRY PRODUCTS TRIG SLIDES
    VANTERA CLINICAL ANALYZER
    ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
    OLYMPUS TRIGLYCERIDE TEST SYSTEM
    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
    VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
    CARESIDE TRGLYCERIDE
    TGL FLEX REAGENT CARTRIDGE
    WAKO L-TYPE TRIGLYCERIDE TEST
    TRIGLYCERIDES, TG, OR TRIG
    DMA TRIGLYCERIDES PROCEDURES
    PARAMAX TRIGLYCERID REAGENT
    OLYMPUS LIPASE REAGENT
    TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
    TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
    HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
    TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
    TRUE TRIGLYCERIDE
    TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
    TRIGLYCERODES QVET
    TRIGLYCERIDES
    TRIGLYCERIDES GPO-PAP
    TRIGLYCERIDES
    SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
    LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
    KING DIAGNOSTIC TRIGLYCERIDES REAGENT
    OLYMPUS TRIGLYCERIDE REAGENT
    BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
    ABBOTT QUICKSTART TIGLYCERIDES REAGENT
    ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
    TRIGLYCERIDES REAGENT SET
    SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
    ECLIPSE ICA TRIGLYCERIDES
    TRIGLYCERIDES REAGENT GPO 5 X CONC.
    SYNERMED TRIGLYCERIDES REAGENT KIT
    COULTER TRIGLYCERIDES GPO REAGENT
    QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
    COBAS READY TRIGLYCERIDE REAGENT
    TRIGLYCERIDES TEST KIT
    AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
    EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
    ROCHE REAGENT FOR TRIGLYCERIDES
    TRIGLYCERIDES - GPO REAGENT
    OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
    TRIGLYCERIDES REAGENT (PRODUCT #88218)
    BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
    TRIGLYCERIDE
    TRIGLYCERIDES (GPO-TRINDER)

    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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