BEUDAMED
    Product Code: PEN FDA class 2 21 CFR 866.3365

    Gram-Negative Bacteria And Associated Resistance Markers

    Microbiology

    The Gram-Negative Bacteria and Associated Resistance Markers assay is a qualitative multiplexed in vitro diagnostic device designed to detect and identify gram-negative bacteria and associated antimicrobial resistance markers, typically from positive blood cultures. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3365, requiring 510(k) premarket notification. Rapid identification of resistant organisms supports timely antimicrobial stewardship and appropriate treatment selection in septic patients. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    11
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    6
    Years Active
    12

    Research product code PEN in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PEN
    Device Class
    FDA class 2
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K243013 LIAISON PLEX Gram-Negative Blood Culture Assay
    K243759 BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
    K213236 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
    K193519 BioFire Blood Culture Identification 2 (BCID2) Panel
    K190341 iC-GN iC-Cassette for use on the iC-System
    K182619 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
    K181493 FilmArray Blood Culture Identification (BCID) Panel
    K160457 FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
    K143171 FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
    K132843 VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
    K130914 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.