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510(k) Data Aggregation

    K Number
    K954607
    Device Name
    RETICULOCYTE METHOD
    Manufacturer
    BAYER CORP.
    Date Cleared
    1996-08-30

    (331 days)

    Product Code
    GKL,GKZ,JPJ
    Regulation Number
    864.5200
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K954594
    Device Name
    RETICULOCYTE METHOD, RBC INDICES
    Manufacturer
    BAYER CORP.
    Date Cleared
    1996-08-23

    (325 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details based on the provided text:

    Acceptance Criteria and Device Performance

    The acceptance criteria for the Technicon H+3 RTC/RTX reticulocyte method are implied by the reported performance characteristics and the stated goals of the evaluation. While explicit threshold values are not given, the device is considered to meet acceptance criteria if its performance is comparable to established methods (NCCLS for reticulocytes) and demonstrates high correlation and low bias for RBC indices.

    Table of Acceptance Criteria (Implied) and Reported Device Performance

    ParameterImplied Acceptance Criteria (e.g., strong correlation, low bias)Reported Device PerformanceStudy Type
    Reticulocyte CountAccuracy (vs. Manual Counts)
    % retic (r)High correlation (e.g., >0.90)0.97Comparison to NCCLS method
    % retic (Slope)Close to 1 (e.g., 0.9-1.1)0.93Comparison to NCCLS method
    % retic (Intercept)Close to 00.0Comparison to NCCLS method
    % retic (Syx)Low error0.56Comparison to NCCLS method
    % retic (Reference Mean)Matches H•3 Mean closely2.0Comparison to NCCLS method
    % retic (H•3 Mean)Matches Reference Mean closely1.9Comparison to NCCLS method
    abs retic (10^9^/L) (r)High correlation (e.g., >0.90)0.93Comparison to NCCLS method
    abs retic (Slope)Close to 1 (e.g., 0.9-1.1)0.86Comparison to NCCLS method
    abs retic (Intercept)Close to 06.4Comparison to NCCLS method
    abs retic (Syx)Low error22.6Comparison to NCCLS method
    abs retic (Reference Mean)Matches H•3 Mean closely84.9Comparison to NCCLS method
    abs retic (H•3 Mean)Matches Reference Mean closely79.1Comparison to NCCLS method
    RBC IndicesAccuracy (vs. H+3 CBC/Diff Mode)
    MCV (r)High correlation (e.g., >0.95)0.974Comparison to H+3 CBC/Diff
    MCV (Slope)Close to 1 (e.g., 0.9-1.1)0.88Comparison to H+3 CBC/Diff
    MCV (Intercept)Close to 010.0Comparison to H+3 CBC/Diff
    MCV (Syx)Low error1.0Comparison to H+3 CBC/Diff
    MCV (Bias)Close to 0-0.1Comparison to H+3 CBC/Diff
    CHCM (r)High correlation (e.g., >0.95)0.988Comparison to H+3 CBC/Diff
    CHCM (Slope)Close to 1 (e.g., 0.9-1.1)1.06Comparison to H+3 CBC/Diff
    CHCM (Intercept)Close to 0-1.6Comparison to H+3 CBC/Diff
    CHCM (Syx)Low error0.7Comparison to H+3 CBC/Diff
    CHCM (Bias)Close to 00.4Comparison to H+3 CBC/Diff
    CH (r)High correlation (e.g., >0.95)0.980Comparison to H+3 CBC/Diff
    CH (Slope)Close to 1 (e.g., 0.9-1.1)0.95Comparison to H+3 CBC/Diff
    CH (Intercept)Close to 02.0Comparison to H+3 CBC/Diff
    CH (Syx)Low error0.6Comparison to H+3 CBC/Diff
    CH (Bias)Close to 00.5Comparison to H+3 CBC/Diff
    RDW (r)High correlation (e.g., >0.90)0.937Comparison to H+3 CBC/Diff
    RDW (Slope)Close to 1 (e.g., 0.9-1.1)1.06Comparison to H+3 CBC/Diff
    RDW (Intercept)Close to 0-0.8Comparison to H+3 CBC/Diff
    RDW (Syx)Low error0.5Comparison to H+3 CBC/Diff
    RDW (Bias)Close to 00.1Comparison to H+3 CBC/Diff
    HDW (r)High correlation (e.g., >0.95)0.990Comparison to H+3 CBC/Diff
    HDW (Slope)Close to 1 (e.9., 0.9-1.1)1.13Comparison to H+3 CBC/Diff
    HDW (Intercept)Close to 0-0.25Comparison to H+3 CBC/Diff
    HDW (Syx)Low error0.14Comparison to H+3 CBC/Diff
    HDW (Bias)Close to 00.11Comparison to H+3 CBC/Diff
    PrecisionLow SD and CVWithin Run Precision
    Retic (%) (CV)Low CV (e.g.,
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