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510(k) Data Aggregation

    K Number
    K254166

    Validate with FDA (Live)

    Device Name
    MDx-Chex for BCN
    Manufacturer
    Streck
    Date Cleared
    2026-03-23

    (90 days)

    Product Code
    PMN
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MDx-Chex for BCN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-negative bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Negative Blood Culture assay on the LIAISON PLEX System. MDx-Chex for BCN Control 1 and Control 2 are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Control 1: Gram-negative bacteria: Acinetobacter baumannii, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; genus: Acinetobacter spp., Pseudomonas spp.; antimicrobial resistance genes: KPC, NDM, and VIM. Control 2: Gram-negative bacteria: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Serratia marcescens; family/genus: Enterobacteriaceae/Morganellaceae, Citrobacter spp., Enterobacter spp., Proteus spp., Salmonella spp.; antimicrobial resistance genes: CTX-M, IMP, MCR, OXA, and SME. This product is not intended to replace manufacturer controls provided with the device.

    Device Description

    MDx-Chex® for BCN is a quality control kit consisting of two controls for the Diasorin LIAISON-PLEX Gram-Negative Blood Culture Assay (BCN). The MDx-Chex for BCN Control 1 is positive for certain pathogens and resistance mechanisms in the LIAISON-PLEX Gram-Negative Blood Culture assay and negative for those contained in MDx-Chex for BCN Control 2. The MDx-Chex for BCN Control 2 is positive for the remaining pathogen and antimicrobial resistance genes in the LIAISON-PLEX Gram-Negative Blood Culture assay and negative for those present in MDx-Chex for BCN Control 1 (See Table 1). Each control mix also contains and controls for blood and blood culture media components that have been identified as assay inhibitors, namely hemoglobin, leukocyte DNA, and anticoagulants.

    MDx-Chex for BCN is also configured as a verification kit (MDx-Chex for BCN Verification Kit) for use at equipment installation, in the development of workflow procedures and for operator proficiency evaluation.

    AI/ML Overview

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