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510(k) Data Aggregation

    K Number
    K221355
    Device Name
    VITROS Immuodiagnostic Products CA 125 II Reagent Pack
    Manufacturer
    Ortho Clinical Diagnostics
    Date Cleared
    2022-12-12

    (216 days)

    Product Code
    LTK
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K983875
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative measurement of OC 125 defined antigen concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System. The VITROS CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

    Device Description

    The VITROS Immunodiagnostic Products CA 125 II Reagent Pack (test) is performed using the VITROS CA 125 II Reagent Pack and VITROS CA 125 II Calibrators on the VITROS 5600 System. An immunometric immunoassay technique is used, which involves the reaction of OC 125 present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-OC 125) bound to Streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (Mouse monoclonal anti- OC 125). Unbound (HRP)-labeled anti-OC 125 antibody conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of conjugate bound is directly proportional to the concentration of OC 125 present in the sample.

    AI/ML Overview

    Here's an analysis of the provided text, outlining the acceptance criteria and study details for the VITROS Immunodiagnostic Products CA 125 II Reagent Pack:

    This document is a 510(k) summary for a medical device ([K221355](https://510k.innolitics.com/search/K221355)) and primarily focuses on demonstrating substantial equivalence to a predicate device. As such, it reports on various analytical performance studies rather than user studies or comparative effectiveness studies involving human readers or AI.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied/Stated)Reported Device Performance
    Precision% CV for various CA 125 concentrations (implied to be within acceptable clinical limits)For Sample 1 (9.09 U/mL): Total SD=0.21, %CV=2.4
    For Sample 2 (29.5 U/mL): Total SD=0.55, %CV=1.9
    For Sample 3 (105 U/mL): Total SD=2.04, %CV=1.9
    For Sample 4 (268 U/mL): Total SD=4.70, %CV=1.8
    For Sample 5 (401 U/mL): Total SD=7.35, %CV=1.8
    For Sample 6 (767 U/mL): Total SD=11.74, %CV=1.5
    Detection CapabilityLimit of Detection (LoD) $\ge$ 5.5 U/mL, Limit of Quantitation (LoQ) $\le$ 5.5 U/mL at 20% CV (designed)LoD: 5.5 U/mL
    LoQ (observed): 0.8 U/mL at 20% CV
    Claimed LoQ: 5.5 U/mL
    LinearityLinear over the measuring range (e.g., 80.0% to 101% recovery, R$^2$ close to 1)Linearity Range: 3.6 to 1288 U/mL
    % Recovery: 80.0% to 101%
    Slope: 0.992 (95% CI: 0.985 to 0.999)
    Intercept: -0.932 (95% CI: -1.075 to -0.788)
    R$^2$: 1.000
    Matrix ComparisonSerum and plasma (Li-Hep, EDTA) deemed equivalent (implied by "Pass" status based on Deming regression results)Li-Hep vs. Serum: Slope=0.984, Intercept=0.160, Correlation=1.000 (Pass)
    EDTA vs. Serum: Slope=0.990, Intercept=0.162, Correlation=1.000 (Pass)
    Analytical Specificity (Interference)Observed bias $\ge$ 10% for specific interferents should be identified. Substances not interfering should have bias < 10%.Interfering Substances (Bias $\ge$ 10%): Hemoglobin (1000 mg/dL yielded 12.6% bias at 10.0 U/mL CA 125), Rheumatoid Factor (1043 U/mL yielded 28.3% bias at 11.4 U/mL CA 125). Total Protein (15.8 g/dL yielded 11.3% bias at 10.0 U/mL CA 125).
    Non-Interfering Substances: A long list of substances showed <10% bias.
    Expected Values (Reference Interval)No more than 10% of healthy donors fall outside the current reference interval ($ \le $ 35 U/mL)Overall (60 donors): 1 female out of 60 fell outside ($ > $ 35 U/mL) for Lot 9991 on VITROS 5600. (1/60 = 1.67% < 10%).
    Method ComparisonStrong correlation and agreement between the new device and the predicate device (Passing Bablok regression parameters close to ideal, e.g., slope ~1, intercept ~0, high correlation coefficient).VITROS 5600 vs. Comparative Method: Slope=1.018 (95% CI: 1.009 to 1.027), Intercept=-0.449 (95% CI: -1.444 to -0.166), Correlation Coefficient=0.999
    Dilution Recovery/ImprecisionProduct requirements met (implied by statement)"The dilution recovery and dilution imprecision product requirements were met..."

    Study Details

    1. Sample Size Used for the Test Set and Data Provenance:

      • Precision: Not explicitly stated for the "test set" in the context of device approval but uses multiple runs, days, and lots for calculation. Each sample shown in the precision table represents multiple determinations over different runs, days, and reagent lots.
      • Detection Capability: Not explicitly stated, but consistent with CLSI EP17-A2.
      • Linearity: 4 replicates from each level of a linearity panel (2 through 15 levels) were collected using three reagent lots. Data for one lot (9991) is presented.
      • Matrix Comparison: n=49 for both Li-Hep and EDTA comparisons.
      • Analytical Specificity: Not explicitly stated, but tested at two CA 125 concentrations (10.0 U/mL and 50.0 U/mL) with various interferent concentrations.
      • Expected Values (Reference Interval): 60 healthy female and male blood donors.
      • Method Comparison: n=146 patient serum samples.
      • Data Provenance: Not explicitly stated, but typical for such studies performed by manufacturers. Generally, such studies are prospective, and data would be collected from various clinical sites. No country of origin is specified.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

      • This device is an in-vitro diagnostic (IVD) assay measuring a quantitative biomarker (CA 125 II antigen concentration). The "ground truth" for these types of devices is based on well-defined analytical methods, reference materials, and established predicate devices. No human experts or consensus panels are typically used to establish ground truth for this type of quantitative IVD device. The "ground truth" here is the actual concentration of the analyte, often determined by a reference method or assigned value of a calibrator.

    3. Adjudication Method for the Test Set:

      • Not applicable as this is an analytical performance study for a quantitative IVD, not a diagnostic imaging or clinical decision-making study that would involve expert interpretation requiring adjudication.

    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:

      • No, an MRMC comparative effectiveness study was not done. This device is a lab-based immunoassay, not an AI-powered diagnostic imaging tool or a system involving human readers in its direct use.

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

      • Yes, the entire submission describes standalone performance. This is an automated immunoassay system (VITROS 5600 Integrated System) that produces a quantitative result. Its performance is entirely "algorithm only" or "device only" in the sense that once a sample is loaded, the measurement is automated without human interpretation of the direct signal to derive the CA 125 concentration. Human interpretation comes into play when a clinician uses the result in conjunction with other clinical findings.

    6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth for the analytical performance studies (precision, linearity, detection, etc.) is the known concentration of the analyte in control materials, calibrators, or spiked samples, or comparison to a legally marketed predicate device (for method comparison).
      • For the method comparison study, the "ground truth" is established by the predicate device's measurement (VITROS CA 125 II (GEM.1125A)).

    7. The Sample Size for the Training Set:

      • Not applicable in the context of an immunoassay using a specific reagent pack and established analytical reactions. This is not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" of the device is its initial calibration and quality control setup based on manufacturer-defined calibrators and controls.

    8. How the Ground Truth for the Training Set Was Established:

      • Not applicable. The "ground truth" for the device's operational setup (calibration) is established by in-house reference calibrators that have been value-assigned to correlate to another commercially available test. These calibrators have known, assigned concentrations of the OC 125 defined antigen.
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