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510(k) Data Aggregation

    K Number
    K073309
    Device Name
    ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
    Manufacturer
    HORIBA ABX
    Date Cleared
    2008-10-17

    (329 days)

    Product Code
    LCP,JIX,JJY
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K031380,K955087,K951361
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ABX PENTRA HBAIc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer

    Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

    The ABX PENTRA HbAIc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAIc WB method on Horiba ABX clinical chemistry analyzers.

    The ABX PENTRA HbAlc WB Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbA1c WB method.

    The ABX PENTRA HbA1c WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbA1c WB method.

    Device Description

    All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

    The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood based on a turbidimetric and colorimetric test. The assay is composed of the following vials:

    • 1 x 23 ml vial (R1) 1 x 23 ml vial (R2) 1 x 110 ml vial (R3) 2 x 21 ml vials (R4) 1 x 25 ml vial (R5)

    Reagent R1 is prepared from substances of animal origin and purified with human material. Reagents R2 and R3 are prepared from substances of animal origin and chemical solutions. R4 and R5 are chemical solutions with additives.

    The ABX PENTRA HbA1c Cal is a liquid multi-calibrator prepared from chemical solutions. It is used for the calibration of the HbA1c assays. The assigned values are given in the notice. This calibrator has six levels and is provided in one vial of 8 ml and five vials of 2 ml.

    The ABX PENTRA HbA1c Control is a lyophilized assayed control prepared from human whole blood. It has 2 levels (Normal and Pathological) to be used for the quality control of HbA 1c assays. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 0.25 ml. The kit contains also a 2 ml reconstitution buffer vial.

    The ABX PENTRA HbA1c WB Hemolysis Reagent is a chemical solution for use in the lysis of red blood cells with the HbA1c HORIBA ABX methods on the ABX Pentra 400 system. It is provided in a 110 ml vial.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA HbA1c WB device, based on the provided 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaABX PENTRA HbA1c WB (Hemolysate/Manual hemolysis method) PerformanceABX PENTRA HbA1c WB (Whole Blood/Automated hemolysis method) Performance
    AccuracyY = 0.97 x + 0.36 (r² = 0.9673)Y = 0.98 x + 0.41 (r² = 0.9561)
    Precision (CV Total)
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