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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: KTN FDA class 2

    System, Test, Infectious Mononucleosis

    Immunology

    View full classification →

    The Infectious Mononucleosis Test System is an in vitro diagnostic device used to detect heterophile antibodies or Epstein-Barr virus-specific antibodies in patient samples to aid in the diagnosis of infectious mononucleosis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before it can be marketed. The product code is KTN, regulated under 21 CFR 866.5640, in the Immunology 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
    OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
    ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
    BIORAPID MONONUCLEOSIS
    COLOR-MONOGEN
    DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
    CLEARVIEW IM
    MONOCOL/LEX-IM TEST
    OSOM MONO TEST 143
    GENZYME DIAGNOSTICS CONTRAST MONO
    BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
    QUALITROL MONO CONTROL SERUM SET
    IMMUNOCARD MONO
    EYE SPOT IM TEST
    ACCUTEX IM LATEX TEST
    BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
    ACCUTEX IM RBC TEST
    PULSE IM RED CELL TEST
    TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
    IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
    INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
    HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
    CARDS O.S. MONO
    MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
    MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
    DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
    LEECO PREVIEW(R) EBV (EIA)
    DETECTADOT SYSTEM 2000 HETEROPHILE TEST
    IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
    MONODEX
    DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
    MONO-CUBE(TM)
    V-TREND TARGET IM TEST
    MODIFICATION OF MONO-PLUS(TM)
    CARDS(TM) MONO
    OXOID INFECTIOUS MONONUCLEOSIS KIT
    MONO-PLUS(TM)
    MONO-PHILE
    V-TREND IM DRY-SPOT TEST
    INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
    I.M.N. LATEX
    DIFFERENTIAL I.M. SCREENING TEST
    VENTRESCREEN (TM) MONO
    DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
    MONO-LATEX (TM) SLIDE TEST
    MONOSTAR SYSTEM: IM LATEX TEST
    GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
    CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
    IMMUNO-IM
    MONOSTICON UNI-DOT
    SERIES I/S INFECTIONS

    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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