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510(k) Data Aggregation

    K Number
    K260281

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-26

    (56 days)

    Product Code
    Regulation Number
    866.1645
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

    VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is a quantitative test. Testing is indicated for Streptococcus pneumoniae as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

    VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) has demonstrated acceptable performance with the following organism:
    Streptococcus pneumoniae

    The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus and Viridans Streptococcus to antimicrobial agents when used as instructed.

    Device Description

    The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).

    Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 – 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

    VITEK® 2 AST-Streptococcus Cefuroxime has the following concentrations in the card: 0.25, 0.5, 1, and 2 (equivalent standard method concentration by efficacy in µg/mL).

    AI/ML Overview

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