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    K Number
    K032932
    Device Name
    DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
    Manufacturer
    STANBIO LABORATORY
    Date Cleared
    2004-03-10

    (170 days)

    Product Code
    LBS,JIX
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K000568
    Why did this record match?
    Device Name :

    DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

    Device Description

    The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    Method ComparisonStrong correlation (R-value approaching 1)Correlation coefficient (R-value): 0.9987 (vs. predicate device)
    Bias (slope near 1, intercept near 0)Regression equation: y = 1.01x - 0.4942 (vs. predicate device)
    PrecisionWithin acceptable range"Results of these tests were within acceptable range."
    Linearity (Analytical Range)Clearly defined upper limitLinear to 200 mg/dl
    SensitivityClearly defined lower detection limitA change of 0.001 absorbance units is equivalent to approximately 0.4 mg/dl of HDL Cholesterol.
    Interference StudiesWithin acceptable range"Results of these tests were within acceptable range."

    Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.

    2. Sample Size and Data Provenance for the Test Set

    • Sample Size: 50 patient samples were used for the correlation (method comparison) study.
    • Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.

    3. Number of Experts and Qualifications for Ground Truth

    • This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.

    4. Adjudication Method for the Test Set

    • This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.

    6. Standalone (Algorithm Only) Performance

    • Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.

    7. Type of Ground Truth Used

    • The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
    • For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."

    8. Sample Size for the Training Set

    • This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.

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

    • This information is not applicable or provided for the reasons stated in point 8.
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