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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: JSE FDA class 1

    Culture Media, Multiple Biochemical Test

    Microbiology

    View full classification →

    The Culture Media, Multiple Biochemical Test is a microbiology diagnostic medium designed to perform multiple biochemical reactions simultaneously in a single inoculation, enabling the identification of microorganisms based on a pattern of metabolic reactions used to differentiate bacterial species in clinical microbiology laboratories. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSE and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MLX MICROTITER PLATE LUMINOMETER
    X-ACT UREA/TDA
    X-ACT LDC/IND
    MRVP BROTH
    MIL MEDIUM
    KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
    CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
    MICRODILUTION IDENTIFICATION PANELS
    BIOTIS LITMUS MILK
    BIOTIS SIM MEDIUM
    BIOTIS TSI
    BIOTIS SIMMON CITRATE AGAR
    BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
    AUSTIN ENTERIC SYSTEM
    CTAPI - NEISSERA SCREEN
    DIFFERENTIAL CULTURE MEDIUM
    LYSINE IRON AGAR LIA
    SIM MEDIUM
    KLIGLER IRON AGAR KIA
    MOTILITY INDOLE ORNITHINE AGAR
    BIOTIS KLIGLER IRON AGAR
    RIM STREP KIT
    BIOTIS LD-PRESUMPTO QUADRANT PLATE
    MULTIPLE BIOCHEMICAL TEST
    KLIGLER IRON AGAR
    MYCOBIOTIC AGAR
    LYSINE IRON AGAR
    MOTILITY INDOLE ORNITHINE-MEDIUM
    SIM MEDIUM
    INDOLE NITRATE MEDIUM
    API 20GP
    CHRISTENSENS CITRATE SULFIDE AGAR
    LECITHIN LACTOSE AGAR
    TRIPLE SUGAR IRON AGAR SLANT
    CULTURE MEDIA, MULTIPLE BIOCHEMICAL
    CULTURE MEDIA, NON-SELECTIVE/DIFFER
    #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
    SUCROSE
    BCYE MEDIUM
    ONPX-INDOL MEDIUM MICROTUBES
    PGUA-INDOL MICROTUBE
    RAPID FERMENTATION AGAR (RFA)
    SIM MEDIUM
    DECARBOXYLASE MOELLER BASE WITH OR WITH-
    TRIPLE SUGAR IRON AGAR (TSI AGAR)
    API 20E REAGENT QC
    CARBOHYDRATE FERMENTATION MEDIA
    AGAR, MOTILITY-NITRATE
    DENTRIFICATION LACTOSE AGAR
    PLATE, LD PRESUMPTO

    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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