BEUDAMED
    Product Code: PCH FDA class 2 21 CFR 866.3990

    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

    Microbiology

    The Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal pathogens (bacterial, viral, and parasitic) from stool specimens. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3990, requiring 510(k) premarket notification. These multiplex panels enable rapid, comprehensive diagnosis of gastrointestinal infections in a single test. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    38
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    16
    Years Active
    13

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    Basic Information

    Product Code
    PCH
    Device Class
    FDA class 2
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 38 510(k) clearances via K numbers.

    K Number Device Name
    K253722 LIAISON PLEX Gastrointestinal Flex Assay
    K254032 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
    K251721 Xpert GI Panel
    K252329 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
    K251993 Panther Fusion GI Expanded Bacterial Assay
    K251868 Panther Fusion GI Bacterial Assay
    K250324 QIAstat-Dx GI Panel 2 Mini B
    K243885 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
    K242877 BioCode Gastrointestinal Pathogen Panel (GPP)
    K243813 QIAstat-Dx GI Panel 2 Mini B&V
    K242367 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
    K220062 QIAstat-Dx Gastrointestinal Panel 2
    K232672 EasyScreen Gastrointestinal Parasite Detection Kit
    K230404 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
    K220607 BD MAX Enteric Viral Panel
    K220193 BD MAX Enteric Parasite Panel
    K191161 xTAG Gastrointestinal Pathogen Panel (GPP)
    K191160 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K182703 EntericBio Dx Assay
    K190585 Biocode Gastrointestinal Pathogen Panel (GPP)
    K183030 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K183023 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K181427 BD MAX Enteric Viral Panel, BD MAX Instrument
    K180041 BioCode Gastrointestinal Pathogen Panel (GPP)
    K170308 BD MAX Extended Enteric Bacterial Panel, BD MAX System
    K160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
    K152955 Great Basin Shiga Toxin Direct Test
    K143648 BD MAX Enteric Parasite Panel, BD MAX Instrument
    K143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
    K142501 Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
    K140647 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
    K142033 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
    K140377 XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
    K140083 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
    K140407 FILMARRAY GASTROINTESTINAL (GI) PANEL
    K121894 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
    K123274 PROGASTRO SSCS ASSAY
    DEN130003 XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.