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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: CFJ FDA class 2

    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

    Clinical Chemistry

    View full classification →

    The NAD Reduction/NADH Oxidation Lactate Dehydrogenase Test is a clinical chemistry device that measures LDH enzyme activity by monitoring the reduction of NAD+ to NADH (or reverse) spectrophotometrically, providing a kinetic measure of LDH used in the evaluation of myocardial infarction, liver disease, and other conditions associated with tissue necrosis. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CFJ, regulated under 21 CFR 862.1440, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
    S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
    PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
    LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
    LIQUID LDH-L REAGENT SET
    LACTATE DEHYDROGENASE (LD)
    LD-L REAGENT
    LACTATE DEHYDROGENASE
    LACTATE DEHYDROGENASE REAGENT SET
    LACTATE DEHYDROGENASE REAGENT SYSTEM
    HICHEM LDH/L REAGENT KIT
    LACTATE DEHYDROGENASE QVET
    LACTATE DEHYDROGENASE (LD)
    LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
    OLYMPUS LACTATE DEHYDROGENASE REAGENT
    OLYMPUS LACTATE DEHYDROGENASE REAGENT
    SYNERMED LDHH-L REAGENT KIT
    DMA LD KINETIC PROCEDURE
    ABBOTT QUICKSTART LDH,#5A31
    SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
    BIOTROL LACTATE DEHYDROGENASE (L-P)
    SYNERMED LDH REAGENT KIT
    AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
    ROCHE REAGENT FOR LDH
    COULTER LD (LDH-L) REAGENT
    COBAS READY LDH REAGENT
    LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
    LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
    LACTATE DEHYDROGENASE LDH
    VISION(R) LDH (LACTATE DEHYDROGENASE)
    LDH-L REAGENT SET
    LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
    LACTATE DEHYDROGENASE LDH-L
    UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
    MULTICHEM LDH-L REAGENT
    ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
    SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
    WAKO(TM) AUTOKIT LDH
    LDH S.C.E.
    LACTATE DEHYDROGENASE(LD) PROCEDURE
    EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
    EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
    KING DIAGNOSTICS LDH TEST
    LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
    LDP REAGENT CARTRIDGE (NO. 88216)
    LACTATE DEHYDROGENASE (LD) PROCEDURE
    HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
    LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
    L D H-L (LACTIC DEHYDROGENASE) REAGENT
    LDH-P (LACTIC DEHYDROGENASE) REAGENT

    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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