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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: NUA FDA class 2

    System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

    Immunology

    View full classification →

    The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System is a molecular diagnostic device that simultaneously detects and identifies a panel of mutations and variants in the CFTR gene, used as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis, carrier identification, and newborn screening. It is not intended for stand-alone diagnostics, prenatal, pre-implantation, or population screening. It is an FDA Class 2 device regulated under 21 CFR 866.5900 in the Immunology specialty, reviewed by the Pathology panel, with product code NUA, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

    510(k) Clearances

    12 matches
    K Number
    Device Name
    xTAG Cystic Fibrosis 39 Kit v2
    xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
    XTAG CF60 KIT V2
    XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
    VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
    ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
    INPLEX CF MOLECULAR TEST
    CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
    TAG-IT CYSTIC FIBROSIS KIT
    ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
    ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
    TAG-IT CYSTIC FIBROSIS KIT

    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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