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    K Number
    K103788
    Device Name
    PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
    Manufacturer
    HORIBA ABX SAS
    Date Cleared
    2011-11-08

    (316 days)

    Product Code
    CFR,CEM,CGZ,JGS,JJE
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K052007
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings. It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride. ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry. 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 I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiometry using ion selective electrode with associated reference solution, calibrators and controls. Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.

    Device Description

    The PENTRA C200 is a benchtop clinical chemistry analyzer using two measuring principles: absorbance and ion selective electrodes. The instrument may be summarized as follows: Multi-parametric (up to 15 simultaneous tests + 3 ISE tests). On routine or Stat. 90 (without ISE) to 360 (with ISE) tests / hour (in single or bi-reaction mode) -(analytical cycle of 40 seconds). random access working on primary tubes or sample cups. ABX PENTRA reagent cassettes are compact and ready-to-use. on board bar-code reader is used to identify newly loaded reagent cassettes and samples for patient identification.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the PENTRA C200, I.S.E. Module, and ABX PENTRA Glucose HK CP, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Note: The document explicitly states "Clinical testing met all acceptance criteria," but does not detail the specific numerical acceptance criteria for each performance metric (e.g., "CV Total ≤ X%"). Instead, it provides the reported performance of the device. For the purpose of this response, the "Acceptance Criteria" column will represent the performance values achieved by the predicate device (if stated or implied to be the benchmark for substantial equivalence) or the general clinical expectations for such devices, and the "Reported Device Performance" column will show the results for the PENTRA C200. Since explicit numerical acceptance criteria for many metrics are not provided beyond the predicate device comparison, I will use the "Reported Device Performance" to demonstrate meeting the general requirement of being "substantially equivalent."

    Performance MetricAnalyteSample TypeAcceptance Criteria (Implied / Predicate)Reported Device Performance (PENTRA C200)
    Accuracy and Precision (CV Total)GlucoseSerum & PlasmaNot explicitly stated (likely ≤ predicate)≤ 1.99%
    Limit of QuantitationGlucoseSerum & PlasmaNot explicitly stated (likely ≤ predicate)5 mg/dL
    Measuring Range (Glucose)GlucoseSerum & PlasmaNot explicitly stated (likely ≥ predicate)5 mg/dL - 900 mg/dL (Automatic post-dilution: 2700 mg/dL)
    Correlation (Glucose)GlucoseSerum & PlasmaNot explicitly stated (likely r² close to 1)Y = 0.98 x + 4.46 (mg/dL) with r² = 0.998
    Calibration StabilityGlucoseN/ANot explicitly stated (likely ≥ predicate)20 days
    Reagent StabilityGlucoseN/ANot explicitly stated (likely ≥ predicate)On-board (refrigerated): 39 days
    Accuracy and Precision (CV Total)SodiumSerum & PlasmaNot explicitly stated (likely ≤ predicate)≤ 1.1 %
    SodiumUrineNot explicitly stated (likely ≤ predicate)≤ 4.91 %
    Linearity & Measuring RangeSodiumSerum & PlasmaNot explicitly stated (likely ≥ predicate)90 - 190 mmol/L
    SodiumUrineNot explicitly stated (likely ≥ predicate)60 – 280 mmol/L
    CorrelationSodiumSerumNot explicitly stated (likely r² close to 1)Y = 0.96 x + 6.42 with r² = 0.982
    SodiumPlasmaNot explicitly stated (likely r² close to 1)Y = 1.05 x - 5.32 with r² = 0.998
    SodiumUrineNot explicitly stated (likely r² close to 1)Y = 1.01 x - 2.20 with r² = 0.989
    Accuracy and Precision (CV Total)PotassiumSerum & PlasmaNot explicitly stated (likely ≤ predicate)≤ 1.07 %
    PotassiumUrineNot explicitly stated (likely ≤ predicate)≤ 2.87 %
    Linearity & Measuring RangePotassiumSerum & PlasmaNot explicitly stated (likely ≥ predicate)2 - 9.5 mmol/L
    PotassiumUrineNot explicitly stated (likely ≥ predicate)25 - 250 mmol/L
    CorrelationPotassiumSerumNot explicitly stated (likely r² close to 1)Y = 1.01 x - 0.06 with r² = 0.998
    PotassiumPlasmaNot explicitly stated (likely r² close to 1)Y = 1.01 x - 0.09 with r² = 0.998
    PotassiumUrineNot explicitly stated (likely r² close to 1)Y = 1.02 x - 0.27 with r² = 0.997
    Accuracy and Precision (CV Total)ChlorideSerum & PlasmaNot explicitly stated (likely ≤ predicate)≤ 1.55 %
    ChlorideUrineNot explicitly stated (likely ≤ predicate)≤ 4.59 %
    Linearity & Measuring RangeChlorideSerum & PlasmaNot explicitly stated (likely ≥ predicate)70 – 170 mmol/L
    ChlorideUrineNot explicitly stated (likely ≥ predicate)70 – 280 mmol/L
    CorrelationChlorideSerumNot explicitly stated (likely r² close to 1)Y = 0.96 x + 3.74 with r² = 0.996
    ChloridePlasmaNot explicitly stated (likely r² close to 1)Y = 1.04 x - 4.17 with r² = 0.997
    ChlorideUrineNot explicitly stated (likely r² close to 1)Y = 1.04 x - 5.63 with r² = 0.987

    Non-Clinical Safety Requirements:

    • IEC 61010-1 / IEC 61010-2-081 / IEC 61010-2-101 (Safety requirements for electrical equipment)
    • EN 61326-2-6 (EMC requirements)
    • UL631010 - 1 / CSA - C22.2 No. 61010-1 (Safety requirements)

    Reported Device Performance: "The PENTRA C200 (with ISE module) meets:" all listed non-clinical safety requirements.

    Study Information

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

      • Glucose: n=103 for correlation study (sample type: Serum & Plasma). Data provenance not specified (retrospective or prospective, country of origin).
      • Sodium:
        • Serum (n=129) for correlation.
        • Plasma (n=132) for correlation.
        • Urine (n=101) for correlation.
        • Data provenance not specified.
      • Potassium:
        • Serum (n=122) for correlation.
        • Plasma (n=125) for correlation.
        • Urine (n=159) for correlation.
        • Data provenance not specified.
      • Chloride:
        • Serum (n=170) for correlation.
        • Plasma (n=131) for correlation.
        • Urine (n=112) for correlation.
        • Data provenance not specified.

      The studies appear to be comparative, correlating the PENTRA C200 results against a reference method or the predicate device. The samples used are described as "Serum & plasma" and "Urine" for the different analytes.

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

      • The document does not specify the use of human experts to establish ground truth. These are clinical chemistry analyzer performance studies, where "ground truth" (or reference values) would typically come from a reference method run on another FDA-cleared device or a defined gold standard lab method.

    3. Adjudication method for the test set:

      • Not applicable as the measured values are compared against a reference/predicate method, not against expert consensus.

    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:

      • Not applicable. This is not an imaging or diagnostic AI device requiring human reader adjudication or assistance. It's a clinical chemistry analyzer.

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

      • Yes, the performance data provided is for the device operating in a standalone capacity, measuring analytes without human intervention in the analytical process itself.

    6. The type of ground truth used:

      • The ground truth (or reference values) for the correlation studies for Glucose, Sodium, Potassium, and Chloride would be obtained from measurements performed by the predicate device (ABX PENTRA 400) as part of the substantial equivalence claim, or another established clinically validated reference method. The correlation equations presented directly compare the candidate device (Y) to an x-value (presumably the predicate or reference method).

    7. The sample size for the training set:

      • Not applicable. This described device is a physical clinical chemistry analyzer, not a machine learning or AI algorithm in the traditional sense that requires a "training set" to learn from data. Its analytical methods (spectrophotometry, potentiometry) are based on established chemical principles.

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

      • Not applicable, as there is no specific "training set" for this type of device.
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