BEUDAMED
    Product Code: NQX FDA class 2 21 CFR 866.1640

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

    Microbiology

    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.

    View on FDA
    510(k)s
    24
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    13
    Years Active
    21

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    Basic Information

    Product Code
    NQX
    Device Class
    FDA class 2
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 24 510(k) clearances via K numbers.

    K Number Device Name
    K243625 Xpert MRSA/SA SSTI
    K243070 Xpert® SA Nasal Complete
    K191742 ARIES MRSA Assay
    K190771 Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
    K162444 Xpert MRSA NxG
    K142721 cobas MRSA/SA Test
    K133605 BD MAX MRSA XT, BD MAX INSTRUMENT
    K132822 BD MAX STAPHSR ASSAY, INSTRUMENT
    K132468 MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
    K130894 XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
    K120138 BD MAX MRSA ASSAY, BD MAX INSTRUMENT
    K112937 MRSA/SA ELITE MGB
    K112424 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
    K102740 NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
    K101879 XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
    K091409 LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
    K100822 XPERT MRSA/SA NASAL ASSAY
    K093346 BD GENEOHM MRSA ACP ASSAY
    K082140 XPERT MRSA/SA BLOOD CULTURE ASSAY
    K080837 XPERT MRSA/SA SSTI ASSAY
    K071026 BD GENEOHM STAPHSR ASSAY
    K070462 XPERT MRSA
    K042357 IDI-MRSA ASSAY
    K033415 IDI-MRSA

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.