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510(k) Data Aggregation

    K Number
    K091711
    Device Name
    S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
    Manufacturer
    ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    2009-12-11

    (184 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K071466,K951361
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

    Device Description

    The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of %HbA1c concentration in EDTA whole blood. This method is based on a colorimetric assay for total hemoglobin and an enzymatic assay for HbA1c.

    AI/ML Overview

    Acceptance Criteria and Study Details for S-Test HbA1c Reagent Cartridge (K091711)

    This document describes the acceptance criteria and supporting study details for the S-Test HbA1c Reagent cartridge, as presented in the 510(k) summary K091711.

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria are inferred from the precision and accuracy data presented in the 510(k) summary. Given this is a diagnostic assay for a quantitative measure, the acceptance criteria are generally focused on demonstrating acceptable levels of precision and linearity/correlation with a comparative method.

    Performance MetricAcceptance Criteria (Inferred)Reported Device Performance
    Precision
    Within-run CV≤ X% (typical clinical range)0.9 to 1.1% (3 HbA1c levels, 20 days, lab)
    0.5 to 1.8% (3 POL sites, 5 days)
    Total CV≤ Y% (typical clinical range)1.2 to 1.5% (3 HbA1c levels, 20 days, lab)
    0.7 to 3.2% (3 POL sites, 5 days)
    Accuracy
    CorrelationCorrelation coefficient $\ge$ 0.950.982 (110 samples, lab)
    0.988 to 0.996 (3 POL sites)
    Slope0.95 to 1.05Confidence Interval: 0.988 to 1.062 (lab)
    Confidence Interval: 0.957 to 1.065 (3 POL sites)
    InterceptClose to 0 (e.g., -0.5 to 0.5)Confidence Interval: -0.48 to 0.02 (lab)
    Confidence Interval: -0.64 to 0.16 (3 POL sites)
    Standard Error of EstimateClinically acceptable (e.g.,
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