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510(k) Data Aggregation

    K Number
    K141426
    Device Name
    ELECSYS FOLATE III
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2014-10-17

    (140 days)

    Product Code
    CGN
    Regulation Number
    862.1295
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k043318,k092740,k082340
    Why did this record match?
    Reference Devices :

    K043318, K092740

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

    Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.

    Device Description

    The Folate III Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with a ruthenium complex). Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.

    AI/ML Overview

    Roche Diagnostics' Elecsys Folate III Assay is a quantitative in vitro diagnostic device designed for measuring folate levels in human serum, primarily for the diagnosis and treatment of anemias. The following outlines its acceptance criteria and the studies performed to demonstrate its performance.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Elecsys Folate III Assay are primarily established through comparison to a predicate device, the Roche Elecsys Folate III (K082340). The device demonstrates comparable or improved analytical performance characteristics.

    FeaturePredicate Device: Roche Elecsys Folate III (K082340)Candidate Device: Elecsys Folate III AssayAcceptance Criteria (Implied by equivalence)
    Measuring Range1.50 - 20.0 ng/mL2.0 - 20.0 ng/mLSimilar or improved range
    Analytical Sensitivity
    Limit of Blank (LoB)0.640 ng/mL0.6 ng/mLEqual to or lower than predicate
    Limit of Detection (LoD)1.50 ng/mL1.2 ng/mLEqual to or lower than predicate
    Limit of Quantitation (LoQ)2.0 ng/mL2.0 ng/mLEqual to or lower than predicate
    Analytical Specificity (Cross-reactivity)
    Amethopterin2.3% at 750 ng/mL2.5% at 1500 ng/mLComparable or improved
    Aminopterin2.7% at 750 ng/mL4.4% at 1500 ng/mLComparable or improved
    Folonic acid2.3% at 750 ng/mL0.7% at 1500 ng/mLComparable or improved
    Precision (cobas e 411)
    Within-run (Repeatability)%CV range: 3.7% - 5.8%%CV range: 2.2% - 6.8%Comparable to predicate
    Total (Intermediate)%CV range: 6.1% - 9.4%%CV range: 3.7% - 10.8%Comparable to predicate
    Limitations (Interference)
    Bilirubinunaffected
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