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510(k) Data Aggregation

    K Number
    K193590
    Device Name
    CareSens S Fit BT Blood Glucose Monitoring System
    Manufacturer
    i-SENS, Inc.
    Date Cleared
    2020-01-17

    (25 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CareSens S Fit BT Blood Glucose Monitoring System

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

    The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

    Device Description

    The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips.

    AI/ML Overview

    This FDA 510(k) clearance letter does not contain the specific acceptance criteria, study details, and performance data requested. It primarily grants market clearance for the CareSens S Fit BT Blood Glucose Monitoring System based on substantial equivalence to predicate devices.

    To answer your questions, I would need access to the actual 510(k) submission summary or a separate performance study report for the device. The provided document only includes:

    • Trade/Device Name: CareSens S Fit BT Blood Glucose Monitoring System
    • Regulation Number: 21 CFR 862.1345
    • Regulation Name: Glucose test system
    • Regulatory Class: Class II
    • Product Code: NBW
    • Indications for Use: The system is intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips, for self-testing by people with diabetes at home to monitor diabetes control. It is for single-person use, not for neonates, and not for diagnosis or screening of diabetes.
    • Type of Use: Over-The-Counter Use

    Without the actual study data, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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