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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: LLH FDA class 1

    Reagents, Clostridium Difficile Toxin

    Microbiology

    View full classification →

    Reagents, Clostridium Difficile Toxin are laboratory reagents used to detect the toxins produced by Clostridium difficile (now Clostridioides difficile) in stool specimens, supporting the diagnosis of C. difficile-associated diarrhea and colitis, a significant healthcare-associated infection. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LLH, regulated under 21 CFR 866.2660, within the Microbiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    SensiTox C. difficile Toxin Test
    OSOM C. DIFFICILE TOXIN A/B TEST
    XPERT C. DIFFICILE
    PROGASTRO CD ASSAY
    C. DIFF QUIK CHEK COMPLETE
    BD GENEOHM CDIFF ASSAY
    VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
    VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
    TOX A/B QUICK CHEK
    XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
    IMMUNOCARD TOXINS A & B, MODEL 712050
    C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96
    PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
    C. DIFF CHEK - 30
    C. DIFF CHEK - 60
    C. DIFFICILE TOX A/B II
    C. DIFFICILE TOX A/B II
    PREMIER TOXINS A&B, MODEL 616096
    CDTOX A OIA
    PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
    COLORPAC TOXIN A
    TOX A/B TEST
    VIDAS C. DIFFICILE TOXIN A II ASSAY
    PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
    IMMUNOCARD TOXIN A
    PROSPECT MICROPLATE ASSAY
    CLOSTRIDIUM DIFFICILE TOX-B TEST
    TECHLAB 1-HOUR TOX-A-TEST
    CULTURETTE BRAND TOXIN CD TEST
    CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
    PREMIER C. DIFFICILE, MODIFICATION
    IMMUNOCARD(TM) C. DIFFICILE
    PREMIER C. DIFFICILE TOXIN A CONTROLS
    CLOSTRIDIUM DIFFICILE TOX-A-TEST
    VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
    BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
    CYTOCLONE A & B EIA
    PREMIER-C. DIFFICILE TOXIN A
    CDT CYTOTOXI TEST
    CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
    MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
    CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI

    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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