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510(k) Data Aggregation

    K Number
    K051147

    Validate with FDA (Live)

    Device Name
    SIDEKICK BLOOD GLUCOSE TEST SYSTEM
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Date Cleared
    2005-07-12

    (69 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    Device Description

    Sidekick Blood Glucose Test System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a blood glucose test system. It does not contain the detailed study information about acceptance criteria and device performance that you requested. Specifically, it lacks:

    • A table of acceptance criteria and reported device performance.
    • Information on sample sizes, data provenance (e.g., country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set.
    • Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used.
    • Sample size for the training set or how its ground truth was established.

    This document is a regulatory clearance, not a clinical study report. To get the information you requested, you would typically need to review the submission's associated clinical and analytical studies, which are not included in this letter.

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