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510(k) Data Aggregation

    K Number
    K100464
    Device Name
    UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
    Manufacturer
    WAKO CHEMICALS USA, INC.
    Date Cleared
    2011-02-23

    (370 days)

    Product Code
    NSF,JIT,JJX,OAU,OUE
    Regulation Number
    866.6030
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K041847,K062368
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The µTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (≥ 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

    The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the µTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment.

    The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The uTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument.

    The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako µTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum.

    The Wako µTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako µTASWako AFP-L3 Immunological Test System.

    The Wako uTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uTASWako AFP-L3 Immunological Test System.

    The Wako µTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum.

    The Wako µTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako µTASWako DCP Immunological Test System.

    The Wako µTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.

    Device Description

    The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that can perform assays of the uTASWako AFP-L3 and µTASWako DCP Immunological Test Systems. This system automatically conducts sampling, mixing, separation, and fluorescence detection on a microfluidic chip to achieve high sensitivity and accuracy. The instrument contains an automated liquid dispenser, temperature controlled reagent container, chip station, analysis compartment, and sample rack station. The outside panel has a printer and a touch panel with a menu to order measurements and to check the availability for reagent, chip, wash solution, and pure water. A chip is used for each test and is disposable. The instrument is designed to automatically and constantly monitor the reagents, chips, dispensing system and the measurement process so that measurement results are not given when an error occurs.

    The system is comprised of the following products:
    uTASWako i30
    uTASWako AFP-L3, Calibrator Set, Control L and Control H
    uTASWako DCP, Calibrator Set, Control L and Control H
    Instrument and assay accessories as per labeling

    AI/ML Overview

    The provided text describes the performance data for the µTASWako i30 Immunoanalyzer System and its associated AFP-L3 and DCP immunological test systems. This is a medical device, and the criteria and studies described relate to analytical performance, not clinical diagnostic accuracy or reader studies with human experts.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Sensitivity (LoD)Not explicitly stated; "distinguished from blank" implied.AFP-L1: 0.030 ng/mLAFP-L3: 0.028 ng/mLDCP: 0.042 ng/mL
    Linearity/Reportable Range"Full assay linearity was demonstrated" over claimed ranges.Total AFP: 0.3 - 1000 ng/mLAFP-L3%: 0.5 - 99.5%DCP: 0.1 - 950 ng/mL
    High Dose Hook Effect"No effect" of high concentration.Total AFP (for AFP-L3 assay): No effect up to 1,272,000 ng/mLDCP (for DCP assay): No effect up to 23,000 ng/mL
    Within-Run PrecisionTotal AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% (≥ 1 ng/mL), within 15% (< 1 ng/mL)Total AFP: 0.7% to 1.5%AFP-L3%: 0.3% to 5.6%DCP: 1.1% to 6.7%
    Total PrecisionTotal AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% (≥ 1 ng/mL), within 15% (< 1 ng/mL)Total AFP: 1.4% to 3.1%AFP-L3%: 0.4% to 6.3%DCP: 1.3% to 7.9%
    Reproducibility (Instrument to Instrument)Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10%Total AFP & AFP-L3%: 1.6% to 2.7%DCP: 4.9% to 5.6%
    RecoveryNot explicitly stated; "evaluated the accuracy" implies acceptable recovery.Total AFP: 97.8% to 104.9%AFP-L3%: 98.1% to 100.9%DCP: 94.0% to 111.6%
    Interference"No significant effect" from potential interferents.Total AFP & AFP-L3%: No significant effect from various interferents.DCP: No significant effect from various interferents (glucose and galactose not tested for DCP).
    HAMA Interference"No significant effect" from HAMA interferents.No significant effect for Total AFP, AFP-L3%, and DCP assays.
    Method Comparison/Correlation"Acceptable correlation" with predicate device; Specific concordance rates for clinical cut-offs.AFP-L3%: Concordance rate of 90.4% (at 10% clinical cut-off) between µTASWako i30 and LiBASys.DCP: Concordance rate of 95.5% (at 7.5 ng/mL clinical cut-off) between µTASWako i30 and LiBASys.
    Stability"Demonstrated stability according to the labeled storage conditions."Long-term stability and stability after opening for reagent, calibrator set, and controls demonstrated. 30-day stability of one-time instrument calibration also supported.

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

    • Sensitivity (LoD): Sample size not specified, but involved distinguishing analytes from blank.
    • Linearity/Assay Reportable Range: Sample size not specified.
    • High Dose Hook Effect: Sample size not specified.
    • Within-Run Precision: Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Number of runs/replicates not specified in summary.
    • Total Precision: 7 pooled human serum samples and 2 levels of controls. Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Measured over 21 days.
    • Reproducibility (Instrument to Instrument): 24 instruments were used. Sample details not explicitly stated, but for AFP-L3 and DCP assays.
    • Recovery: Sample details not explicitly stated.
    • Interference: Tested with known amounts of various interfering substances. Sample details not explicitly stated.
    • HAMA Interference: Tested with two types of HAMA interferents. Sample details not explicitly stated.
    • Method Comparison/Correlation (AFP-L3 and DCP):
      • Test Set: 200 samples from 100 patients.
      • Additionally:
        • AFP-L3: 40 serum samples spiked with AFP-L1 and AFP-L3.
        • DCP: 20 serum samples spiked with DCP.
      • Data Provenance: Not explicitly stated, but the studies were conducted to support a US FDA 510(k) submission, suggesting a focus on samples relevant to the intended patient population, likely from clinical settings. It is retrospective in the sense that the samples are collected and then tested.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This document describes the analytical performance of an in vitro diagnostic (IVD) device. The "ground truth" for these types of studies is based on the quantitative measurement of analytes and comparison to a legally marketed predicate device (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems). Therefore, human expert judgment in the diagnostic sense (e.g., radiologists interpreting images) is not applicable or described in this context. The "ground truth" for the method comparison studies would be the results obtained from the predicate device (LiBASys).

    4. Adjudication Method for the Test Set

    Not applicable. The studies described are analytical performance studies, not subjective diagnostic interpretations requiring adjudication.

    5. 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 IVD immunoassay system, not an AI-assisted diagnostic imaging device that involves human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    The performance data presented is inherently "standalone" in the context of the device's function, as it evaluates the instrument and test systems' analytical capabilities directly. The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that performs sampling, mixing, separation, and fluorescence detection. Its output (quantitative measurements of AFP-L3% and DCP) does not involve human interpretation in the same way an AI imaging algorithm would. The method comparison studies compare the new device's automated results directly against a predicate automated device.

    7. The Type of Ground Truth Used

    The ground truth for the analytical performance studies is largely based on:

    • Reference Standards: For sensitivity and linearity, the accurate measurement of known concentrations of analytes.
    • Predicate Device Results: For the method comparison/correlation studies, the results obtained from the legally marketed predicate devices (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems) are used as the comparative "ground truth."
    • Clinical Cut-off Values: For calculating concordance rates (e.g., 10% for AFP-L3%, 7.5 ng/mL for DCP), these are established clinical values, not derived from a de novo ground truth for the study but rather applied to the measured values.

    8. The Sample Size for the Training Set

    The document does not describe a "training set" in the context of machine learning or AI development. These are validation studies for an IVD device. The methods described include validation of reagents, calibrators, and system performance through various analytical tests (precision, linearity, recovery, etc.).

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

    Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The studies conducted are for analytical validation of an IVD system against established analytical performance metrics and comparison to a predicate device.

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