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510(k) Data Aggregation

    K Number
    K082631
    Device Name
    THROMBO TEK PSE, MODEL 90-480
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2008-12-17

    (98 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K913424
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ThromboTek PSe is intended for the quantitative determination of functional Protein S activity in human plasma.

    ThromboTek PSe is intended for the quantitative determination of functional Protein S activity, such as when identifying inherited or acquired Protein S deficiency.

    Device Description

    ThromboTek PSe is a tissue factor pathway based clotting assay. The assay activator is a lyophilized preparation incorporating rabbit thromboplastin, calcium, buffer, and stabilizers. The remaining components of the assay are lyophilized activated Protein C, lyophilized human plasma depleted of Protein S, Imidazole buffered saline for use as a plasma diluent, and deionized water containing a preservative for reconstitution of the lyophilized components.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the ThromboTek PSe assay, based on the provided K082631 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (Implied)Reported Device Performance
    PrecisionLow %CV for both normal and abnormal plasma samples.Normal Plasma: Repeatability 4.9% CV, Total 5.7% CV
    Abnormal Plasma: Repeatability 7.8% CV, Total 9.2% CV
    LinearityLinear across the clinically relevant range.Linear from 10% Protein S to 156% Protein S (maximum tested).
    Analytical SensitivityLow limit of detection for Protein S activity.1% Protein S.
    InterferencesMinimal impact from common interferants at specified concentrations (e.g., <10% shift in recovered value).Hemolysis (Hemoglobin): Tolerated up to 500 mg/dL
    Icterus (Unconjugated Bilirubin): Tolerated up to 20 mg/dL
    Lipemia (IntraLipid®): Tolerated up to 2,000 mg triglyceride/dL
    Heparin: Tolerated up to 1.0 U/mL (Tested up to 2.0 U/mL)
    Normal Reference RangeClinically reasonable range for healthy individuals.All Donors (n=120): Mean 120% PS, Range 47% - 193% PS
    Males only (n=35): Mean 135% PS, Range 62% - 209% PS
    Females only (n=85): Mean 114% PS, Range 45% - 183% PS
    Method ComparisonStrong correlation with a legally marketed predicate device.Correlation Coefficient: 0.895 (95% CI, 0.875-0.912)
    Coefficient of Determination: 0.801
    Slope: 1.71, Intercept: -8.59
    Reconstituted StabilitySpecified stability period at various storage conditions.2-8°C: 24 hours
    Room temperature (23-25°C): 8 hours
    Accelerated StabilityPredicted expiry dating based on heat stress.Predicted Expiry: 2 years when stored at 2-8°C.

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

    • Precision:
      • Sample Size: Not explicitly stated as individual samples. Studies used a "normal plasma" and an "abnormal plasma" across three lots of the device over 20 days (two runs per day).
      • Data Provenance: Not specified, but likely internal laboratory data (retrospective/concurrent testing).
    • Linearity:
      • Sample Size: Not explicitly stated. Three lots of the device were used.
      • Data Provenance: Not specified, likely internal laboratory data.
    • Analytical Sensitivity:
      • Sample Size: Replicate measurement of "IBS alone" (presumably a blank or very low concentration sample) for three lots of the device. The number of replicates is not specified.
      • Data Provenance: Not specified, likely internal laboratory data.
    • Interferences:
      • Sample Size: "Pooled normal plasma" spiked with interferants, and a dilution series prepared. Multiple lots of the device were used. The number of individual samples or replicates is not specified.
      • Data Provenance: Not specified, likely internal laboratory data.
    • Normal Reference Range:
      • Sample Size: One hundred twenty (120) healthy donors.
      • Data Provenance: Not specified, but generally, such studies involve prospective collection of samples from healthy individuals.
    • Method Comparison:
      • Sample Size: One hundred seventy-four (174) patient samples.
      • Data Provenance: Collected from "two sites." Given the clinical nature of patient samples, this refers to prospective or retrospective patient samples from those sites. The country of origin is not specified but presumed to be US given the FDA submission.
    • Reconstituted Stability:
      • Sample Size: Two control plasmas. Three lots of the device were assessed.
      • Data Provenance: Not specified, likely internal laboratory data.
    • Accelerated Stability:
      • Sample Size: Three lots of control plasmas. One lot of the ThromboTek PSe lyophilized components was stressed.
      • Data Provenance: Not specified, likely internal laboratory data.

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

    This device (ThromboTek PSe) is an in vitro diagnostic (IVD) assay for quantitative determination of Protein S activity. The concept of "ground truth" established by experts in the context of this device differs from image-based or clinical diagnosis AI algorithms. For this type of IVD, the "ground truth" is typically established by:

    • Analytical methods and reference standards: For linearity, sensitivity, precision, and interference, the "ground truth" is the known concentration, expected performance, or absence/presence of interferants as precisely measured and controlled in the laboratory.
    • Reference materials/standards: For the normal reference range, the results are compared against universally accepted ranges for healthy populations or specific reference materials (e.g., SSC/ISTH Secondary Coagulation Standard Lot #3 from NIBSC was used for calibration).
    • Predicate device results: For method comparison, the results from the legally marketed predicate device (StaClot® Protein S) serve as the comparative "ground truth."

    Therefore, there were no "experts" in the sense of radiologists or pathologists providing consensus diagnoses. Instead, the ground truth was based on established laboratory methods, validated reference materials, and comparison with an approved predicate device.

    4. Adjudication Method for the Test Set

    Not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., imaging where multiple readers independently assess findings, and discrepancies are resolved). For quantitative assays, the results are numerical and are compared against reference values, other assay results, or statistical criteria.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in tasks like image interpretation. The ThromboTek PSe is a standalone diagnostic assay, not an AI-assisted tool for human interpretation.

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

    Yes, the ThromboTek PSe is a standalone in vitro diagnostic device. All performance characteristics (precision, linearity, sensitivity, interference, normal range determination, method comparison, and stability) were evaluated for the assay itself, without a human-in-the-loop component for interpretation or diagnosis. The device provides a quantitative output (Protein S activity percentage).

    7. The Type of Ground Truth Used

    The ground truth used for performance evaluation was a combination of:

    • Reference Standards/Known Concentrations: For analytical sensitivity, linearity, and precision, the "ground truth" was derived from precisely prepared samples with known (or expected) Protein S concentrations or matrix compositions. Calibration was performed using the SSC/ISTH Secondary Coagulation Standard Lot #3.
    • Assay results from a predicate device: For method comparison, the results from the StaClot® Protein S assay served as the comparative ground truth.
    • Clinically Defined Populations: For normal reference range, the ground truth was derived from the Protein S activity measured in a cohort of healthy donors.

    8. The Sample Size for the Training Set

    This filing describes a traditional IVD assay, not a machine learning or AI-driven device. Therefore, there is no "training set" in the typical machine learning sense. The device's performance is based on its chemical/biological reaction principles and direct measurement, not on learning from a dataset.

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

    Since there is no "training set" for an AI algorithm, this question is not applicable. The device's operational principles are pre-defined by its reagents and methodology, not learned from data.

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