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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: KHE FDA class 2

    Reagent, Occult Blood

    Hematology

    View full classification →

    Occult Blood Reagent is an in vitro diagnostic device used to detect the presence of hidden (occult) blood in patient samples such as stool, gastric aspirates, or other body fluids, serving as a screening tool for gastrointestinal bleeding and related conditions. 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 KHE, regulated under 21 CFR 864.6550, within the Hematology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Instant-view-PLUS immunochemical Fecal Occult Blood Test
    InSure ONE
    hema-screen SPECIFIC Gold
    Wondfo One Step Fecal Occult Blood (FOB) Test
    hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
    OC-Light S FIT
    OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
    IND ONE STEP OCCULT BLOOD (FOB) TEST
    FOB ONE STEP RAPID TEST
    HEMA SCREEN ER
    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
    BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
    HEMOCCULT ICT
    DBEST ONE STEP OCCULT BLOOD TEST KITS
    FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
    INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
    FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
    INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
    OCCULTECH FECAL OCCULT BLOOD RAPID TEST
    FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
    HEMA SCREEN SPECIFIC IFOBT
    INSURE II
    IMMOCARE
    CARE FECAL OCCULT BLOOD TEST, MODEL KT313
    POLYMEDCO OC LIGHT FOBT TEST
    HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
    ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
    HEMAPROMPT GASTRIC
    COLONCARE
    LIFEGUARD
    INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
    EASE-A-CULT
    INSTACCULT
    !NSURE FECAL OCCULT BLOOD TEST
    COLOSCREEN-ES
    COLON ALERT TEST
    DBEST OCCULT BLOOD TEST KIT
    HEMAPROMPT
    COLOSCREEN-ES
    HEMAPROMPT
    FLEXSURE OBT
    HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES
    PROPPER SUPER SERACULT(R)
    HEMOPLUS
    HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
    COLOSCREEN
    COLOCARE
    FHT (FECAL HEME TEST)
    MONOHAEM (FECAL OCCULT BLOOD TEST)
    HEMA-SCREEN

    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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