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510(k) Data Aggregation

    K Number
    K211672
    Device Name
    MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
    Manufacturer
    Liofilchem S. R. L.
    Date Cleared
    2021-10-20

    (141 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA letter (K211672) is for an Antimicrobial Susceptibility Test Powder (MTS Piperacillin-tazobactam). This type of device is used to determine the susceptibility of microorganisms to antimicrobial agents, which is crucial for guiding antibiotic treatment. The information provided in the FDA letter and its attachments does not typically contain the detailed performance study information common for AI/ML-based medical devices or imaging analysis software.

    Therefore, many of the specific details requested in your prompt (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size, AI assistance) are not applicable (N/A) to this specific device/submission type, as it is a microbiology culture-based test, not an AI/ML device.

    However, I can extract the relevant information regarding the acceptance criteria and performance as typically presented for such devices.

    Here's the summary based on the provided documents:

    1. A table of acceptance criteria and the reported device performance

    For Antimicrobial Susceptibility Testing (AST) devices like this, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device and achieving acceptable Essential Agreement (EA) and Category Agreement (CA) with a reference method (e.g., CLSI broth microdilution). The acceptance criteria often align with FDA guidance for AST devices.

    Acceptance Criteria CategorySpecific Criteria (Typical for AST)Reported Device Performance (Implied from Clearance)
    Preamble CriteriaSubstantial Equivalence to PredicateWas found "substantially equivalent" for stated indications.
    Primary Performance EndpointsEssential Agreement (EA) ≥ 90%Implied to have met required EA thresholds for all tested organisms/drugs.
    Category Agreement (CA) ≥ 90%Implied to have met required CA thresholds for all tested organisms/drugs.
    Secondary Performance EndpointsMajor Discrepancies (MD) rate ≤ 3%Implied to be within acceptable limits.
    Very Major Discrepancies (VMD) rate ≤ 1.5%Implied to be within acceptable limits.
    Reproducibility/PrecisionConsistent results across replicates and sitesImplied to have demonstrated acceptable reproducibility and precision.
    No Growth/Contamination
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