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510(k) Data Aggregation

    K Number
    K971636
    Device Name
    RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1998-01-28

    (271 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., and modified by procedures, Haemophilus influenzae.

    Device Description

    Oxoid Rifampicin Susceptibility Test Disc

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an in vitro diagnostic device (IVD), specifically an antimicrobial susceptibility test disc. IVDs, especially those cleared under a 510(k), are often evaluated based on their performance characteristics compared to a predicate device, rather than a full clinical study with acceptance criteria like a drug or a novel medical device. The document itself does not contain the detailed study results or acceptance criteria.

    However, based on the nature of antimicrobial susceptibility testing and the typical requirements for such devices, I can infer and generally describe the likely acceptance criteria and type of study. I will fill in the table and information, making educated assumptions where the specific details are not provided in the given text.

    I must emphasize that the provided text does not include the detailed study results or acceptance criteria directly. This information would typically be in the 510(k) submission itself, which this document is a response to.

    1. Table of Acceptance Criteria and Reported Device Performance

    For an antimicrobial susceptibility test disc, the primary performance metrics are related to its ability to accurately classify bacterial isolates as susceptible, intermediate, or resistant to a given antibiotic (Rifampicin in this case). The acceptance criteria are typically established in comparison to a reference method (e.g., broth microdilution or agar dilution as described by CLSI/NCCLS standards).

    Acceptance Criteria (Inferred)Reported Device Performance (Inferred/Typical for 510k IVD)
    Essential Agreement (EA): Percentage of isolates where the disc diffusion category (S, I, R) matches the reference method category.Typically >90% (often 95-99%) for each drug-bug combination. For the Oxoid Rifampicin disc, it would need to demonstrate high essential agreement across relevant Staphylococcus spp. and Haemophilus influenzae. The exact reported percentage is not in this document.
    Category Agreement (CA): Percentage of isolates where the disc diffusion category (S, I, R) exactly matches the reference method category (similar to EA but sometimes used to denote a stricter match).Typically >90% (often 95-99%). The exact reported percentage is not in this document.
    Minor Discrepancies: Percentage of isolates with a one-off category difference (e.g., reference is Susceptible, disc is Intermediate).Typically
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