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510(k) Data Aggregation

    K Number
    K230887
    Device Name
    Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
    Manufacturer
    Sysmex America, Inc.
    Date Cleared
    2023-12-21

    (265 days)

    Product Code
    GKZ,81G,81J,81K,81P
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K032677,K112605
    Why did this record match?
    Reference Devices :

    K032677

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

    The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

    Device Description

    The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer.

    Important Note: This document is a 510(k) summary, which provides a high-level overview of the studies. It does not contain the detailed acceptance criteria for every test or the raw data. The acceptance criteria described are inferred from the statements that "All results met the predefined acceptance criteria" or similar. The "reported device performance" in the table below will be the results stated as meeting those (unspecified) criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document describes various performance studies. Below is a table summarizing the reported performance, with the understanding that for each, "predefined acceptance criteria" were met. Specific numeric acceptance criteria are generally not provided in this summary.

    Study TypeAcceptance Criteria (Inferred)Reported Device Performance
    Method ComparisonRegression analysis (slope, intercept, correlation coefficient, bias) and Bland-Altman plots demonstrating agreement with predicate.WBC: N=378, Range 0.31-98.67, Correlation 0.9994, Slope 0.992 (0.988-0.996 CI), Intercept 0.215 (0.144-0.285 CI)
    RBC: N=385, Range 1.10-6.78, Correlation 0.9984, Slope 0.970 (0.965-0.976 CI), Intercept 0.107 (0.083-0.130 CI)
    HGB: N=385, Range 3.2-23.8, Correlation 0.9987, Slope 0.974 (0.969-0.979 CI), Intercept 0.45 (0.39-0.52 CI)
    HCT: N=379, Range 11.1-59.1, Correlation 0.9965, Slope 0.964 (0.956-0.972 CI), Intercept 0.62 (0.30-0.93 CI)
    MCV: N=385, Range 52.5-131.6, Correlation 0.9881, Slope 1.005 (0.990-1.021 CI), Intercept -1.98 (-3.43 to -0.53 CI)
    MCH: N=385, Range 13.1-40.9, Correlation 0.9861, Slope 0.997 (0.981-1.014 CI), Intercept 0.57 (0.08-1.06 CI)
    MCHC: N=385, Range 22.4-40.2, Correlation 0.8914, Slope 0.880 (0.839-0.922 CI), Intercept 4.83 (3.52-6.13 CI)
    PLT: N=382, Range 6-941, Correlation 0.9960, Slope 0.989 (0.980-0.998 CI), Intercept -1.9 (-4.9 to 1.0 CI)
    RDW-SD: N=384, Range 33.6-105.5, Correlation 0.9467, Slope 1.028 (0.995-1.062 CI), Intercept -5.03 (-6.83 to -3.23 CI)
    RDW-CV: N=385, Range 11.2-26.5, Correlation 0.9645, Slope 1.167 (1.136-1.198 CI), Intercept -3.15 (-3.65 to -2.65 CI)
    MPV: N=359, Range 8.2-14.5, Correlation 0.9027, Slope 0.912 (0.870-0.954 CI), Intercept 0.40 (-0.05 to 0.86 CI)
    NEUT#: N=262, Range 0.36-57.75, Correlation 0.9959, Slope 1.020 (1.009-1.031 CI), Intercept -0.176 (-0.299 to -0.052 CI)
    Lymph#: N=363, Range 0.10-99.84, Correlation 0.9962, Slope 1.012 (1.003-1.021 CI), Intercept 0.109 (-0.005 to 0.222 CI)
    MXD#: N=262, Range 0.02-3.00, Correlation 0.8525, Slope 1.280 (1.197-1.364 CI), Intercept -0.247 (-0.394 to -0.101 CI)
    NEUT%: N=262, Range 15.9-96.7, Correlation 0.9600, Slope 1.017 (0.981-1.052 CI), Intercept -2.32 (-4.58 to -0.06 CI)
    LYMPH%: N=364, Range 0.5-95.2, Correlation 0.9827, Slope 1.031 (1.011-1.051 CI), Intercept 0.18 (-0.56 to 0.91 CI)
    MXD%: N=262, Range 1.0-18.0, Correlation 0.5933, Slope 1.415 (1.268 to 1.562 CI), Intercept -4.25 (-6.06 to -2.44 CI)
    Sensitivity & Specificity (Flagging)Meeting predefined overall percent agreement criteria for detecting abnormal distributional and morphological flags.Three External Sites:
    Any Abnormal Distributional Flag: N=237, Sensitivity 89.5% (83.29-94.01 CI), Specificity 75.5% (65.58-83.81 CI), Overall % Agreement 84.0% (78.66-88.40 CI)
    Any Abnormal Morphological Flag: N=353, Sensitivity 74.5% (67.08-81.06 CI), Specificity 76.0% (69.37-81.89 CI), Overall % Agreement 75.4% (70.52-79.76 CI)
    Any Abnormal Distributional and/or Abnormal Morphological Flag: N=360, Sensitivity 90.7% (86.36-94.01 CI), Specificity 56.6% (46.99-65.93 CI), Overall % Agreement 80.0% (75.49-84.01 CI)
    One Internal Site:
    Any Abnormal Distributional Flag: N=200, Sensitivity 91.4% (83.00-96.45 CI), Specificity 92.4% (86.13-96.48 CI), Overall % Agreement 92.0% (87.33-95.36 CI)
    Any Abnormal Morphological Flag: N=189, Sensitivity 28.2% (15.00-44.87 CI), Specificity 94.0% (88.92-97.22 CI), Overall % Agreement 80.4% (74.04-85.83 CI)
    Any Abnormal Distributional and/or Abnormal Morphological Flag: N=200, Sensitivity 83.5% (74.27-90.47 CI), Specificity 91.7% (84.90-96.15 CI), Overall % Agreement 88.0% (82.67-92.16 CI)
    Precision (Repeatability)Pooled results meeting predefined acceptance criteria for mean, SD, and %CV across various target levels.All pooled results met predefined acceptance criteria for all measured parameters (WBC, RBC, HGB, HCT, PLT, MCV, MCH, MCHC, RDW-SD, RDW-CV, MPV, NEUT#/% LYMPH#/% MXD#/%). (Specific values are in the provided tables in the source document, indicating they met the criteria).
    ReproducibilityAll results meeting predefined acceptance criteria for within-run, between-run, between-day, between-site, and total imprecision.All results met predefined acceptance criteria. (Specific values are in the provided tables in the source document, indicating they met the criteria).
    LinearityMeeting predefined acceptance criteria across the claimed linearity ranges.All results met the predefined acceptance criteria. Claimed linearity ranges provided for WBC, RBC, HGB, HCT, PLT.
    CarryoverResults determining acceptable levels of carryover.All results were determined to be acceptable.
    Interfering Substances StudyNo significant interference for specified substances up to certain concentrations.No significant interference observed for Bilirubin F (40.0 mg/dL), Bilirubin C (40 mg/dL), Hemolytic Hemoglobin (800 mg/dL for HGB, 400 mg/dL for MCHC; 1,000 mg/dL for others), Lipids (0.20 g/dL for HGB, MCH, MCHC; 1.00 g/dL for MPV; 2.00 g/dL for others), High WBC counts (93.53 x 10^3 cells/µL for RBC, HGB, HCT, MCV; 72.08 x 10^3 cells/µL for PLT), High RBC counts (upper measuring range for WBC, RBC, HGB, PLT; 6.64 x 10^6 cells/µL for HCT), High PLT counts (955 x 10^3 cells/µL for WBC, RBC, HGB, HCT, PLT, MPV). Significant chyle interference was observed for MXD# at 720 FTU.
    LoB, LoD, LoQMeeting manufacturer's specifications.Met manufacturer's specifications. Reported values: WBC (LoB 0.00, LoD 0.03, LoQ 0.17), RBC (LoB 0.00, LoD 0.01, LoQ 0.01), HGB (LoB 0.0, LoD 0.1, LoQ 0.1), HCT (LoB 0.0, LoD 0.1, LoQ 0.1), PLT (LoB 0, LoD 1, LoQ 2).
    Sample StabilitySupporting the claimed storage conditions in the instructions for use.Supports 12 hours at room temperature (18-26°C) and 24 hours at refrigerated temperature (2-8°C).
    Anticoagulant ComparabilityRegression analysis and bias estimates meeting acceptance criteria.Results met the acceptance criteria.
    Venous vs. Capillary BloodRegression analysis and bias estimates meeting acceptance criteria.Results met acceptance criteria.
    Normal Tubes vs. Micro-collectionRegression analysis and bias estimates meeting acceptance criteria.Results met acceptance criteria.
    Whole Blood vs. Predilute ModeRegression analysis and bias estimates meeting acceptance criteria.Results met acceptance criteria.
    Reference Intervals VerificationNormal ranges for adults and pediatric subpopulations consistent with established ranges/literature.Reference intervals for adults determined acceptable (proposed intervals overlapped 95% CI). Pediatric samples consistent with literature. MXD# and MXD% ranges from predicate (Sysmex pocH-100i) are applicable.

    2. Sample Sizes and Data Provenance

    • Test Set (Method Comparison & Sensitivity/Specificity):
      • Method Comparison: 628 unique residual and prospectively collected venous whole blood samples from pediatrics (
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