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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: NQX FDA class 2

    System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

    Microbiology

    View full classification →

    The MRSA Direct Specimen Nucleic Acid Amplification Test System is a diagnostic device that uses nucleic acid amplification, including probes and reagents, to identify methicillin-resistant Staphylococcus aureus (MRSA) colonization status directly from patient specimens. It is used as an aid in the prevention and control of MRSA infections within healthcare settings. The device falls under FDA Class 2, meaning it requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is NQX, regulated under 21 CFR 866.1640, and falls within the Microbiology medical specialty. It is not an implant and does not provide life-sustaining support.

    510(k) Clearances

    24 matches
    K Number
    Device Name
    Xpert MRSA/SA SSTI
    Xpert® SA Nasal Complete
    ARIES MRSA Assay
    Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
    Xpert MRSA NxG
    cobas MRSA/SA Test
    BD MAX MRSA XT, BD MAX INSTRUMENT
    BD MAX STAPHSR ASSAY, INSTRUMENT
    MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
    XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
    BD MAX MRSA ASSAY, BD MAX INSTRUMENT
    MRSA/SA ELITE MGB
    VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
    NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
    XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
    LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
    XPERT MRSA/SA NASAL ASSAY
    BD GENEOHM MRSA ACP ASSAY
    XPERT MRSA/SA BLOOD CULTURE ASSAY
    XPERT MRSA/SA SSTI ASSAY
    BD GENEOHM STAPHSR ASSAY
    XPERT MRSA
    IDI-MRSA ASSAY
    IDI-MRSA

    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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