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510(k) Data Aggregation

    K Number
    K151530
    Device Name
    CardioChek Plus Test System
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    2015-07-07

    (29 days)

    Product Code
    CGA,CHH,JGY,LBR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k142302,k140068
    Why did this record match?
    Reference Devices :

    K142302

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

    The CardioChek Plus Test System is a small portable analyzer and test strip system intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer.

    • Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

    • HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

    • Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

    • Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

    Device Description

    The CardioChek Plus Test System includes the CardioChek Plus professional analyzer and analyte-specific test strips (PTS Panels eGLU test strips, PTS Panels Glucose test strips and PTS Panels Lipid Panel test strips). The CardioChek Plus Test System is modified in this submission by the addition of the CardioChek ChekMate strips. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.

    AI/ML Overview

    The provided text describes the CardioChek Plus Test System and its modification with the addition of CardioChek ChekMate strips. The 510(k) summary focuses on the performance characteristics of these new ChekMate strips, particularly their precision and stability.

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

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it reports on the precision of the CardioChek ChekMate strips.

    Performance CharacteristicAcceptance Criteria (Implicit from Results)Reported Device Performance (CardioChek ChekMate Strips)
    Intermediate Precision (% CV)
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