LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110583
    Device Name
    SENSITITRE OPTIREAD
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Date Cleared
    2011-09-22

    (205 days)

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

    SENSITITRE OPTIREAD

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

    The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

    The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

    The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

    Device Description

    The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Sensititre® OptiRead™, an antimicrobial susceptibility test powder reader. It does not contain the detailed study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
    2. Sample sizes used for the test set and the data provenance: This information is not present.
    3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
    4. Adjudication method: This information is not present.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
    6. If a standalone performance study was done: This information is not present.
    7. The type of ground truth used: This information is not present.
    8. The sample size for the training set: This information is not present.
    9. How the ground truth for the training set was established: This information is not present.

    The document focuses on the regulatory clearance and the device's indications for use, not the specifics of its validation studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1