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510(k) Data Aggregation

    K Number
    K172201
    Device Name
    Atellica IM Folate Assay
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2018-04-12

    (265 days)

    Product Code
    CGN
    Regulation Number
    862.1295
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K010050
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.

    Device Description

    The Atellica™ IM Folate Assay is an immunoassay with the following components: Atellica™ IM Folate Primary Reagent ReadyPack (including Lite Reagent, Solid Phase Reagent, and Folate Binding Protein), Atellica™ IM Folate Calibrator (including Low and High Calibrators), Atellica IM Folate DTT/Releasing Agent (sold separately, including Dithiothreitol and Sodium hydroxide), and Atellica IM RBC Folate (sold separately, including Lyophilized ascorbic acid and RBC Folate Ascorbic Acid Diluent).

    AI/ML Overview

    The provided text is a 510(k) summary for an in vitro diagnostic device (Atellica™ IM Folate Assay), not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device acceptance criteria and study design (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) is not applicable to this document.

    However, I can extract information related to the acceptance criteria for this diagnostic assay and how its performance was proven.

    Here's a summary based on the provided document, addressing the applicable points:

    Device Name: Atellica™ IM Folate Assay

    Indications for Use: For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a singular table, but rather presents performance characteristics of the device, implying that the observed performance met internal or regulatory (CLSI) standards. The predicate device (ADVIA Centaur Folate Assay, K010050) serves as the benchmark for substantial equivalence.

    Here's a compilation of key performance characteristics, acting as de-facto acceptance criteria for a new in vitro diagnostic assay, and the reported performance. The "Acceptance Criteria" here are implicitly derived from CLSI guidelines and comparison to the predicate.

    Performance CharacteristicImplicit/Stated Acceptance Criteria (often based on CLSI guidelines or predicate performance)Reported Device Performance (Atellica™ IM Folate Assay)
    Precision (Repeatability CV)Acceptable Coefficient of Variation (CV) for different analyte levels (e.g., typically <10% for low concentrations, <5% for higher)Serum Control 1: 3.3% Serum Control 2: 2.5% Serum 1: N/A Serum 2: 2.4% Serum 3: 2.9% Serum 4: 2.6% (Similar data for Whole Blood samples)
    Precision (Within-Lab CV)Acceptable Coefficient of Variation (CV)Serum Control 1: 6.1% Serum Control 2: 6.4% Serum 1: N/A Serum 2: 5.9% Serum 3: 5.9% Serum 4: 6.5% (Similar data for Whole Blood samples)
    Linearity (Serum)Bias from linear fit estimate <10% across the measuring range.Bias from linear fit estimate <10% (except sample E with 10.44% and G with -8.27% but still within reasonable limits for biological assays). Assay linear from 0.56 to 24 ng/mL.
    Linearity (RBC)Linear relationship with previously cleared device's values.Linear relationship between 0.98 to 17.51 ng/mL.
    Dilution RecoveryRecoveries generally close to 100% (e.g., 90-110%).Recoveries ranged from 102.6%-110.0% (mean 105.4%).
    Spiking RecoveryRecoveries generally close to 100% (e.g., 90-110%).Recoveries ranged from 87%-116% (mean 104%).
    Method Comparison (Correlation r)High correlation coefficient (e.g., r > 0.95) with predicate device.Serum: r = 0.99 RBC hemolysate: r = 0.93
    Method Comparison (Regression Equation)Slope and intercept close to 1 and 0, respectively, when compared to predicate.Serum: y = 0.94x - 0.01 ng/mL RBC hemolysate: y = 1.06x – 2.52 ng/mL
    Detection Limits (LoB, LoD, LoQ)Values demonstrated to be fit for clinical purpose.Serum: LoB 0.19 ng/mL, LoD 0.38 ng/mL, LoQ 0.56 ng/mL RBC: LoB 0.00 ng/mL, LoD 0.21 ng/mL, LoQ 0.56 ng/mL
    InterferenceNo significant interference (<10% effect) from common endogenous and exogenous substances at specified concentrations.No indication of interference (< 10% effect) up to the claimed interferent levels for all tested substances.
    Cross-ReactivityLow cross-reactivity (e.g., ≤ 5%) with related compounds.Amethopterin: ≤2% Aminopterin: ≤1% Folinic Acid: <4%
    Shelf-life StabilityStable until expiration date under specified storage.Stable until expiration date printed on carton @ 2-8 °C.
    On-board StabilityStable for specified duration on the analyzer.14 days; pack calibration interval of 7 days, lot calibration interval of 14 days.

    2. Sample Sizes Used for the Test Set and Data Provenance

    • Precision Study:
      • Serum: 4 human serum samples + 2 control levels. Tested 80 times each (N=80).
      • Whole Blood: 5 whole blood samples + 2 control levels. Tested 80 times each (N=80).
      • Provenance: Not explicitly stated, but typically clinical samples from a diverse patient population within the manufacturer's operational regions (often global or US/EU). Implied to be retrospective for the testing as the samples are "tested".
    • Linearity Study:
      • Serum: 9 samples (prepared from high and low human serum pools). Each tested in triplicate.
      • RBC: 11 samples (prepared from previously cleared device's values).
    • Dilution Recovery: 5 human serum samples. Each run in triplicate.
    • Spiking Recovery: 5 samples (human serum pools with added folate stock).
    • Method Comparison:
      • Human Serum: 105 samples.
      • Human Whole Blood: 100 samples.
      • Provenance: Not explicitly stated, but clinical samples.
    • Collection Tube Comparison: 90 samples (K2 EDTA Whole Blood vs. Lithium Heparin Whole Blood).
    • Reference Intervals Verification:
      • Serum: 30 serum samples from apparently healthy individuals.
      • RBC: 25 RBC samples (whole blood with tested percent hematocrit) from apparently healthy individuals.
    • Detection Limits: Not specified as a sample size, but uses CLSI EP17-A2 protocol, which involves multiple replicates of blank, low-concentration, and standard samples.
    • Interference: Two human sample pools (one approx. 4.0 ng/mL Folate, second approx. 12.0 ng/mL Folate). Both spiked with potential interferents.
    • Cross-Reactivity: Normal human serum sample and blank assay diluent for each test compound. Multiple replicates processed.

    Data Provenance: Not explicitly stated as "country of origin," but given it's a Siemens Healthcare Diagnostics product, it's likely multi-site clinical samples, possibly from North America and/or Europe. The studies are described as lab-based performance studies using human samples, fitting a retrospective data collection model for the test set.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This section is not applicable as this is an in vitro diagnostic assay for quantitative determination of an analyte (folate) using chemical/immunological reactions, not an AI/ML device requiring interpretation of complex images or data by human experts. The "ground truth" for this device is the actual concentration of folate in the samples, determined either by highly accurate reference methods or by comparison to an established, legally marketed predicate device (ADVIA Centaur Folate assay).

    4. Adjudication Method for the Test Set

    Not applicable. As a quantitative in vitro diagnostic device, there is no need for expert adjudication. The result is a numerical concentration.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    Not applicable. MRMC studies are specific to AI/ML devices that assist human readers in interpreting medical images or other complex data. This is a lab-based immunoassay.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Applicable, but in a different context. The "standalone" performance for this device refers to the ability of the Atellica IM Analyzer and reagents to accurately and precisely measure folate concentration without human intervention influencing the measurement itself (beyond loading samples and initiating tests). The performance characteristics listed (precision, linearity, detection limits, etc.) are all measures of the standalone analytical performance of the device.

    7. The Type of Ground Truth Used

    The ground truth for this in vitro diagnostic device is established using:

    • Reference Methods/Internal Standards: Traceability is stated as being to an "internal standard manufactured using highly purified material (N-5-methyl tetrahydrofolate)." Calibrator values are traceable to this standardization.
    • Comparison to a Legally Marketed Predicate Device: The primary method for demonstrating substantial equivalence is by comparing performance (method comparison studies) to the existing, FDA-cleared ADVIA Centaur Folate Assay (K010050). The predicate's results serve as a de-facto "ground truth" for demonstrating equivalence in clinical performance.
    • Known Concentrations: For studies like linearity, dilution, spiking, and detection limits, samples with pre-defined or precisely measured concentrations are used as ground truth.
    • Clinically Defined Samples: Healthy donor samples for reference interval verification.

    8. The Sample Size for the Training Set

    Not applicable in the AI/ML context. This is not an AI/ML device that undergoes a "training" phase with a dataset. The "training" for such an in vitro diagnostic device involves the manufacturer's internal development and optimization of the assay formulation, reagents, and instrument parameters to achieve desired performance, not data-driven model training.

    9. How the Ground Truth for the Training Set was Established

    Not applicable for an AI/ML training set. For the development of the assay itself, the ground truth for optimizing the assay would involve various analytical chemistry techniques and reference materials to ensure the assay accurately measures folate, coupled with comparison to existing validated methods or the predicate device during development phases.

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