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510(k) Data Aggregation

    K Number
    K982669
    Device Name
    OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1998-09-09

    (40 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

    Antimicrose Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. Streptomycin 300 Susceptibility Test Discs are for the screening of Enterococcus of 'high level antibiotic resistance'.

    Device Description

    Oxoid Streptomycin Susceptibility Test Disc

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding a 510(k) submission for an antimicrobial susceptibility test disc. It discusses regulatory matters, but it does not detail:

    1. Acceptance criteria or device performance.
    2. Sample sizes or data provenance for a test set.
    3. Details about expert qualifications or numbers for ground truth establishment.
    4. Adjudication methods.
    5. Multi-reader multi-case study information.
    6. Standalone performance studies.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Therefore, I cannot provide the requested information based on the input text.

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