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510(k) Data Aggregation

    K Number
    K082340
    Device Name
    ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2009-06-19

    (308 days)

    Product Code
    CGN,JIT,JJX,JJY
    Regulation Number
    862.1295
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K973674,K043318,K051292,K042490,K043320,K051517
    Predicate For
    K103716,K111506,K141426
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    (1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.

    (2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.

    (3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

    (4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

    (5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

    Device Description

    (1) The Elecsys 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 ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

    (2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.

    (3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.

    (4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.

    (5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.

    AI/ML Overview

    The Elecsys Folate III Test System, including Elecsys Folate III, Elecsys RBC Folate Hemolyzing Reagent, Elecsys Folate III CalSet, Elecsys Folate III CalCheck, and Elecsys PreciControl Anemia, is designed for the in vitro quantitative determination of folate in human serum, plasma, and erythrocytes. This system is intended for use in the diagnosis and treatment of anemias on Elecsys and cobas e immunoassay analyzers.

    The acceptance criteria for the Elecsys Folate III and Elecsys RBC Folate Hemolyzing Reagent assays were established through comparison studies against their respective predicate devices (Elecsys Folate II Assay and Elecsys RBC Folate Hemolyzing Reagent (K051292)). The primary method for proving the device meets these criteria is through Method Comparison studies using Passing-Bablok and Linear Regression analysis.

    Here's the breakdown of the acceptance criteria and performance:

    Acceptance Criteria CategoryAcceptance Criteria (Predicate Device)Reported Device Performance (Elecsys Folate III)
    Elecsys Folate III Assay
    Measuring Range0.600 - 20.00 ng/mL1.5 - 20.0 ng/mL
    Precision (Total CV for Human Samples < 10 ng/mL)6.1-13.8%7.0-13.3%
    Precision (Total CV for Human Samples > 10 ng/mL)7.0%5.0%
    Analytical Sensitivity (Lower Detection Limit)0.6 ng/mLLimit of Detection = ≤1.5 ng/mL
    Interferences (Icterus)recovery within ± 10% of initial value for bilirubin < 684 µmol/Lrecovery within ± 10% of initial value for bilirubin < 564 µmol/L
    Interferences (Lipemia)recovery within ± 10% of initial value for Intralipid < 1500 mg/dLrecovery within ± 10% of initial value for Intralipid < 1500 mg/dL
    Interferences (Biotin)recovery within ± 10% of initial value for biotin < 123 nmol/Lrecovery within ± 10% of initial value for biotin < 86.1 nmol/L
    Interferences (IgG)recovery within ± 10% of initial value for IgG < 16 g/Lrecovery within ± 10% of initial value for IgG < 16 g/L
    Interferences (IgA)recovery within ± 10% of initial value for IgA < 4.0 g/Lrecovery within ± 10% of initial value for IgA < 4.0 g/L
    Elecsys RBC Folate Hemolyzing Reagent
    Measuring Range (without hematocrit consideration)up to 620 ng/mL46.5 – 572 ng/mL
    Precision (Total CV for sample 1)6.8% CV @ 478 ng/mL7.0% CV @ 229 ng/mL
    Precision (Total CV for sample 2)6.6% CV @ 573 ng/mL7.2% CV @ 350 ng/mL
    Precision (Total CV for sample 3)5.5% CV @ 623 ng/mL7.2% CV @ 481 ng/mL
    Method Comparison (Folate III Assay)Passing/Bablock: Slope = 1.13, Y intercept = -0.10, tau = 0.833; Linear Regression: Slope = 1.13, Y intercept = -0.06, r=0.962
    Method Comparison (RBC Folate Hemolyzing Reagent)Passing/Bablock: Slope = 1.096, tau = 0.700; Linear Regression: Slope = 1.019, r = 0.921

    Study Details:

    1. Sample sizes used for the test set and data provenance:

      • Elecsys Folate III Assay (Method Comparison): N=98 samples. Sample concentrations were between approximately 1.76 and 15.9 ng/mL. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned.
      • Elecsys RBC Folate Hemolyzing Reagent (Method Comparison): N=98 samples. Sample concentrations were between approximately 123 and 566 ng/mL. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned.
      • Elecsys RBC Folate Hemolyzing Reagent (Expected Values): N=262 samples from a study in the USA. This suggests a prospective study for establishing typical ranges.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic assay that measures a biochemical marker (folate concentration). Ground truth for measured analytes is typically established by reference methods or validated assays, not by expert consensus. The comparison is made against the predicate devices' measurements.

    3. Adjudication method for the test set: Not applicable. The studies are method comparisons against a predicate device, not diagnostic performance studies requiring adjudication of disagreements among experts.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human reader interpretation.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay system (Elecsys Folate III assay run on Elecsys and cobas e immunoassay analyzers). The performance data presented (measuring range, precision, sensitivity, interferences, method comparison) reflects the standalone performance of the assay and the instrument system, without human intervention in the measurement process itself, beyond standard laboratory procedures for sample handling and instrument operation.

    6. The type of ground truth used: For the method comparison studies, the "ground truth" was the measurements obtained by the predicate devices: Elecsys Folate II assay for serum folate and Elecsys RBC Folate Hemolyzing Reagent + Elecsys Folate II assay for RBC folate. This is a form of comparative reference standard.

    7. The sample size for the training set: Not applicable. As an in vitro diagnostic assay, there is no "training set" in the context of machine learning or AI models. The assay performance is developed and validated through a series of analytical studies.

    8. How the ground truth for the training set was established: Not applicable. See point 7.

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