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    K Number
    K171247
    Device Name
    epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
    Manufacturer
    Epocal Inc.
    Date Cleared
    2018-01-17

    (264 days)

    Product Code
    CDS
    Regulation Number
    862.1770
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k061597,k090109,k092849,k093297,k113726,K053110
    Why did this record match?
    Reference Devices :

    K061597, K090109, K092849, K093297, K113726

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

    The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.

    Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.

    Device Description

    The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.

    The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per K061597, K090109, K092849, K093297, and K113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.

    AI/ML Overview

    The epoc Blood Urea Nitrogen Test and epoc Total Carbon Dioxide Test, as part of the epoc Blood Analysis System, are intended for use by trained medical professionals as an in vitro diagnostic device for quantitative testing of heparinized or un-anticoagulated arterial, venous or capillary whole blood.

    The acceptance criteria and device performance are described in several studies:

    Acceptance Criteria and Device Performance:

    StudyAcceptance CriteriaReported Device Performance
    Analytical Sensitivity (LoB, LoD, LoQ per CLSI EP17-A2)Not explicitly stated as acceptance criteria, but demonstrates detection limits.BUN: LoB 2 mg/dL, LoD 3 mg/dL, LoQ 3 mg/dL
    TCO2: LoB 4.0 mM, LoD 4.3 mM, LoQ 4.3 mM
    Linearity (per CLSI EP06-A)Not explicitly stated as acceptance criteria, but demonstrates linearity across reportable range.BUN (4-119 mg/dL): Slope 1.020, Intercept 0.4, R 0.9989
    TCO2 (4-49 mmol/L): Slope 0.903, Intercept 3.32, R 0.9997
    Precision (Aqueous Controls) (CLSI EP05-A3)Not explicitly stated as acceptance criteria, but demonstrates precision.BUN High Level (51.7 mg/dL): SWR 1.01 (2.0% CV), ST 1.16 (2.3% CV)
    BUN Low Level (7.1 mg/dL): SWR 0.30 (4.2% CV), ST 0.32 (4.5% CV)
    TCO2 High Level (30.7 mmol/L): SWR 0.82 (2.7% CV), ST 0.92 (3.0% CV)
    TCO2 Low Level (16.2 mmol/L): SWR 0.88 (5.4% CV), ST 1.02 (6.3% CV)
    Interference (CLSI EP07-A2)Unacceptable interference bias defined as producing a significant error more than 5% of the time.Clinically significant interfering substances for BUN and TCO2 are itemized and reported. Various exogenous and endogenous interferences were tested and found to be clinically insignificant below certain thresholds.
    Clinical Field Precision (Aqueous Controls) (CLSI EP05-A3)Not explicitly stated as acceptance criteria, but demonstrates precision in a clinical setting.BUN Level 1 (52.1 mg/dL): SWR 1.06 (2.0%), Total Reproducibility 1.54 (3.0%)
    BUN Level 2 (17.7 mg/dL): SWR 0.45 (2.5%), Total Reproducibility 1.11 (6.3%)
    BUN Level 3 (7.1 mg/dL): SWR 0.24 (3.4%), Total Reproducibility 0.26 (3.7%)
    TCO2 Level 1 (15.9 mM): SWR 0.44 (2.8%), Total Reproducibility 0.50 (3.1%)
    TCO2 Level 2 (19.7 mM): SWR 0.66 (3.4%), Total Reproducibility 0.78 (3.9%)
    TCO2 Level 3 (30.4 mM): SWR 0.58 (1.9%), Total Reproducibility 1.05 (3.4%)
    Clinical Field Precision (Whole Blood)Not explicitly stated as acceptance criteria, but demonstrates precision in a clinical setting.BUN Hi-Syringe (57.4 mg/dL): %CV 2.3%
    BUN Lo-Cap Tube (7.6 mg/dL): %CV 7.0%
    TCO2 Hi-Syringe (36.5 mM): %CV 1.5%
    TCO2 Lo-Cap Tube (13.5 mM): %CV 3.5%
    Method Comparison (BUN) (CLSI EP09-A3)Not explicitly stated as a numerical acceptance criterion, but implies a high correlation with the reference method.Comparing epoc BUN to Roche Cobas 8000: Slope 0.985, Intercept 0.3, R 0.998, Mean Bias at 26 mg/dL -0.1+0.2
    Method Comparison (TCO2)Not explicitly stated as a numerical acceptance criterion, but implies a high correlation with the reference method.Comparing epoc TCO2 to i-STAT-CHEM8+: Slope 1.039, Intercept -0.8, R 0.974, Mean Bias at 20 mM 0.0+0.2
    Matrix Comparison: AnticoagulantNo significant difference between results in Li-heparinized, Na-heparinized, and non-anticoagulated blood samplesConcluded no significant difference in BUN and TCO2 results.

    Study Information:

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

      • Analytical Sensitivity (LoB, LoD, LoQ): Test samples were prepared from dialyzed whole blood. The specific number of samples or runs is not explicitly stated, but the study was conducted according to CLSI EP17-A2.
      • Linearity: Multiple whole blood samples were used, spanning the reportable range. Conducted per CLSI EP06-A. Specific number not provided.
      • Precision (Aqueous Controls): 320 replicates for each level of both BUN and TCO2. These were in-house measurements.
      • Clinical Field Precision (Aqueous Controls): N=170 for BUN Level 1, 171 for Level 2, 168 for Level 3. N=172 for TCO2 Level 1, 170 for Level 2, 169 for Level 3. Data provenance is from "three different clinical sites."
      • Clinical Field Precision (Whole Blood): N=134-136 for BUN samples, N=134-139 for TCO2 samples, depending on the type (syringe/cap tube) and level (high/NB/low). Data provenance is from "three different clinical sites."
      • Precision (Duplicate Epoc Test Results): Over 430 patient tests run in duplicate. "Approximately equal numbers of venous, arterial and capillary samples." Data provenance not explicitly stated (e.g., country of origin), assumed to be from clinical sites in the context of "Clinical Field Precision." This is prospective clinical data.
      • Method Comparison (BUN): N=433 venous, arterial, and capillary blood samples. Performed at "three clinical sites." This is prospective clinical data.
      • Method Comparison (TCO2): N=574 venous, arterial, and capillary patient samples. Performed at "three clinical sites." This is prospective clinical data.
      • Matrix Comparison: Anticoagulant: Over 60 volunteer donors, with samples further aliquoted into 3 vacutainers each. Data provenance not explicitly stated.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quantitative diagnostic test for chemical analytes (BUN, TCO2), not an imaging or qualitative diagnostic device requiring expert interpretation for ground truth. The ground truth for analytical performance studies is typically established using reference methods (e.g., IDMS-traceable laboratory system) or prepared reference materials.

    3. Adjudication method for the test set: Not applicable. The ground truth for quantitative chemical analytes is established by reference methods or gravimetric preparation, not through human 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: Not applicable. This device is a diagnostic testing system for chemical analytes, not an AI-assisted diagnostic imaging or qualitative interpretation tool for human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the entire performance characterization (analytical sensitivity, linearity, precision, interference, method comparison, and matrix comparison) represents standalone algorithm/device performance. The device provides quantitative results directly. Human-in-the-loop performance is about accuracy of human readers, and the clinical field precision study assesses the precision of the device in the hands of intended users, not the interpretative performance of those users.

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

      • Analytical Sensitivity, Linearity, Precision: Ground truth established via prepared reference materials (dialyzed whole blood, gravimetric mixtures of high/low samples) and aqueous controls with known concentrations.
      • Method Comparison (BUN): Ground truth established by an "IDMS-traceable plasma/serum-based laboratory system" (Roche Cobas 8000).
      • Method Comparison (TCO2): Ground truth established by a "whole blood point-of-care system" (i-STAT-CHEM8+), which is also a predicate device.
      • Interference and Matrix Comparison: Comparisons were made against control samples (e.g., solvent added, or anticoagulant-free) to assess the impact of interfering substances or different matrices.

    7. The sample size for the training set: Not applicable. This document describes the performance of a chemical analyte detection system, not a machine learning or AI model that requires a training set.

    8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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