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    K Number
    K100398
    Device Name
    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    STANDARD DIAGNOSTICS, INC.
    Date Cleared
    2010-06-09

    (113 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K082683
    Why did this record match?
    Device Name :

    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

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

    SmartLink™ GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.

    The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.

    Testing is done outside the body (in vitro diagnostic use).

    This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

    This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

    Device Description

    The SmartLink™ GOLD Blood Glucose System is an Rx/OTC blood glucose system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.

    The SmartLink™ GOLD Blood Glucose System consists of a SmartLink™ GOLD Blood Glucose Meter which measures and displays test results, SmartLink™ GOLD test strip, lancet and lancing device for blood sampling, control solution to check the meter and test strip, check strip to check the meter, 3 V battery (type 2032) for power, carrying case, user guide, packaging inserts for the test strip and control solution and a Quick Guide for helping the user with a self test diary to document test results for monitoring the trend of blood glucose.

    The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The svstem can also set the pre-meal and postmeal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document references compliance with EN ISO 15197:2003. This standard outlines specific accuracy criteria for blood glucose monitoring systems. While the exact numerical criteria from the standard are not explicitly listed in this document, the submission confirms that the device "met all relevant standards requirements" (Page 3).

    Acceptance Criteria (Based on EN ISO 15197:2003, typically)Reported Device Performance
    Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires:
    • 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations
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