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510(k) Data Aggregation

    K Number
    K162382
    Device Name
    Smart Dongle Blood Glucose Monitoring System
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2017-04-14

    (233 days)

    Product Code
    NBW,JQP,LFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k101509
    Why did this record match?
    Device Name :

    Smart Dongle Blood Glucose Monitoring System

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

    The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

    Device Description

    The system consists of blood glucose meter, test strips and mobile platform (as a display of the system). And, the blood glucose meter is compatible to iPhone series, including iPhone 4, iPhone 4s, iPhone 5, iPhone 5s, iPhone 6, iPhone 6 plus, iPhone 6s plus. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Smart Dongle Blood Glucose Test Strips can be used only with the Smart Dongle Blood Glucose Monitoring System.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Smart Dongle Blood Glucose Monitoring System. It describes the device, its intended use, and performance characteristics to establish substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Smart Dongle Blood Glucose Monitoring System appear to be based on accuracy performance metrics, specifically comparing the device's readings to reference measurements. While explicit "acceptance criteria" are not phrased as such, the results presented imply the thresholds the device aims to meet.

    Acceptance Criteria (Implied)Reported Device Performance
    **For glucose concentration
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