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510(k) Data Aggregation

    K Number
    K142302
    Device Name
    BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
    Manufacturer
    Polymer Technology Systems, Inc.
    Date Cleared
    2014-10-02

    (45 days)

    Product Code
    CGA,CHH,JGY,LBR,MRR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k071507,k070017
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' office and convalescent care facility bedside testing. 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.

    The Chol+Glu Test Panel system is intended to measure cholesterol and glucose in whole blood on a BioScamer Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.

    The Lipid Panel Test system is intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure three blood analytes: cholesterol and triglycerides. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. 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 mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

    The PTS PANELS HDL Cholesterol Test system is intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

    The PTS PANELS CHOL+HDL Panel Test system is intended to be used by medical professionals to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.

    The PTS PANELS CHOL+HDL+GLU Panel Test system is intended to be used by medical professionals to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

    The PTS PANELS Metabolic Chemistry Panel Test system is intended to be used by medical professionals to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. 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 mellitus, nephrosis, liver diseases involving lipid metabolism or various endocrine disorders.

    Device Description

    The above named test systems are for in vitro diagnostic use with the prescription use BioScanner Plus (CardioChek PA) reflectance photometer.

    The above named test systems are modified in this submission by the addition of a CardioChek ChekMate strip for use only with the prescription use analyzer. 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 document describes the BioScanner Plus Glucose Test System and related PTS PANELS test systems. The primary focus of the performance characteristics section is on the CardioChek ChekMate strips, which are a modification to the system. While the document mentions several test systems and their intended uses (glucose, cholesterol, triglycerides, HDL cholesterol), the performance data specifically addresses the ChekMate strips, which are used to check the analyzer's optics, calibration, and result handling. The information regarding the various analyte test systems largely defers to previously cleared strips and an unmodified analyzer, indicating their performance was established in prior submissions.

    Here's a breakdown of the acceptance criteria and study information for the CardioChek ChekMate Strips:

    Table of Acceptance Criteria and Reported Device Performance (for CardioChek ChekMate Strips)

    Acceptance Criteria CategoryAcceptance CriteriaReported Device Performance
    Value Assignment: Range AppropriatenessRange (MAX – MIN) must be at least 5% R but not more than 10% R.Not explicitly stated what the calculated ranges were, but the document states "The range is acceptable if it is at least 5% R, but not more than 10% R."
    Value Assignment: Individual Strip VerificationEvery ChekMate strip, when measured on a different CardioChek PA meter, must pass the established acceptable ranges.The document states, "Every ChekMate strip is then measured...to verify that every strip will pass these ranges." Implies compliance.
    Real-time Stability: Percent RecoveryPercent recovery ((Result - Result baseline) * 100) must be 100±20%.All four lots at each of the two levels passed the criterion.
    Re-use Stability: Failure Rate on First TestLess than 2% failures on the first test.The acceptance criteria was met for 1,253 uses. (Implying <2% failures).
    Re-use Stability: Failure Rate on Re-testNo failures upon re-test, if a test result did not meet the range initially.The acceptance criteria was met for 1,253 uses. (Implying no failures on re-test).

    Study Details for CardioChek ChekMate Strips:

    1. Sample sizes used for the test set and the data provenance:

      • Value Assignment Test Set: 45 strips evaluated on a single CardioChek PA meter, and then "Every ChekMate strip" (up to 400 pieces per lot) was measured on a different CardioChek PA meter.
      • Real-time Stability Test Set: Four (4) lots of ChekMate strips.
      • Re-use Stability Test Set: Individual ChekMate strips were tested for 1,253 uses across 13 CardioChek PA analyzers.
      • Data Provenance: Not explicitly stated, but typically such studies are conducted by the manufacturer (Polymer Technology Systems, Inc.) in the USA. The document does not specify if the data is retrospective or prospective, but stability studies are inherently prospective.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This device (CardioChek ChekMate strips) is a quality control/verification strip, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" for the ChekMate strips is based on instrument readings (% R values) against predefined acceptable ranges and stability curves. Therefore, no human experts were involved in establishing the ground truth for these strips.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable. The evaluation criteria for the ChekMate strips are objective, numerical measurements of % R values and their adherence to predefined ranges and stability criteria. There is no need for expert adjudication.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No. This is an in vitro diagnostic device for quantitative measurements of analytes or, in the case of ChekMate strips, for verification of an instrument. It is not an AI-assisted diagnostic tool that would involve human readers or an MRMC study.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • The ChekMate strips themselves do not operate as an algorithm in isolation. They are physical strips used with an analyzer. The document describes the performance of the strips in verifying the analyzer's functions (optics, calibration, result handling algorithms). The analyzer itself (CardioChek PA) operates in a "standalone" fashion to generate a result from the strip, but the performance evaluation here is focused on the strips and their ability to consistently produce expected values within the analyzer. The algorithms referred to are integral to the analyzer's function, not a separate AI system.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • For the ChekMate strips, the ground truth is established through internal scientific and engineering processes, likely involving highly calibrated reference instruments and defined chemical/optical properties. The "acceptable ranges" and "baseline results" are the ground truth for testing these verification strips.

    7. The sample size for the training set:

      • Not applicable. This document describes the performance of an in vitro diagnostic device (and its quality control strips). It does not involve machine learning or AI models that require a separate "training set."

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no "training set" in the context of this device's performance evaluation.
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