LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984261
    Device Name
    SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    LIFESCAN, INC.
    Date Cleared
    1999-05-21

    (175 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K942455,k970556
    Predicate For
    K031501,K043512,K043543,K051285,K051651,K052469,K061431,K082201
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.

    Device Description

    The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested table and detailed information based on this input.

    The document is a 510(k) summary and approval letter for the LifeScan SURESTEP Blood Glucose Monitoring System, primarily focusing on its substantial equivalence to previously marketed devices and its intended use. There is no mention of performance studies or acceptance criteria within the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1