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    K Number
    K161679
    Device Name
    s LDL-EX SEIKEN
    Manufacturer
    DENKA SEIKEN CO., LTD.
    Date Cleared
    2017-08-18

    (427 days)

    Product Code
    PYP
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K111516
    Why did this record match?
    Device Name :

    s LDL-EX SEIKEN

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

    The s LDL-EX"SEIKEN" test is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma. The s LDL-EX"SEIKEN" test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.

    Device Description

    The assay consists of two steps and is based on the technique to use well-characterized surfactants and enzymes that selectively react with certain groups of lipoproteins.

    In the first step, non-sd LDL lipoproteins, that is, chylomicrons, VLDL, IDL, L-LDL and HDL are decomposed by a surfactant and sphingomyelinase in Reagent-1 that is reactive to those non-sd LDL lipoproteins. The cholesterol released from such non-sd LDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase.

    In the second step, another surfactant in Reagent-2 releases cholesterol only from sd LDL particles and cholesterol released from sd LDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in Reagent-2, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, develop a purple-red color with the coupler in the presence of peroxidase (POD).

    AI/ML Overview

    The provided text describes the acceptance criteria and a study demonstrating that the device meets these criteria. The device is the s LDL-EX "SEIKEN" test, which is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma.

    Here's an analysis of the requested information based on the provided text:

    1. Table of acceptance criteria and the reported device performance

    The document details performance characteristics rather than explicit "acceptance criteria" for a specific disease detection task, as this is a quantitative diagnostic test. The acceptance is based on the device's analytical performance and its ability to distinguish risk groups for CHD.

    Performance CharacteristicAcceptance Criteria (Implicit)Reported Device PerformanceStudy Type
    Limit of Blank (LoB)Not explicitly stated, but lower is better.0.20 mg/dLAnalytical Performance
    Limit of Detection (LoD)Not explicitly stated, but lower is better.0.38 mg/dLAnalytical Performance
    Limit of Quantitation (LoQ)%CVs less than 10% for the lowest concentration.1.14 mg/dLAnalytical Performance
    Precision (Within-laboratory %CV)%CV for each control/sample, at each site.Range: 1.3% to 4.3% across different sites and samples.Analytical Performance
    Linearity (Nonlinearity)Absolute value of nonlinearity less than allowable nonlinearity.Absolute value of nonlinearity was less than allowable nonlinearity at all tested levels. Linear throughout 4.0 - 100 mg/dL.Analytical Performance
    Spike and Recovery (% difference)Not explicitly stated, but low % difference is desired.Range: -0.5% to +1.3%.Analytical Performance
    Interferences (Hemoglobin)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 1,000 mg/dL.Analytical Performance
    Interferences (Bilirubin)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 60 mg/dL (conjugated and unconjugated).Analytical Performance
    Interferences (Chyle)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 1,420 FTU.Analytical Performance
    Interferences (Sodium L-ascorbate)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 100 mg/dL.Analytical Performance
    Interferences (Intralipid)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 10%. (up to 1% wt/vol as soybean oil).Analytical Performance
    Interferences (Uric acid)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 15 mg/dL.Analytical Performance
    Interferences (Triglyceride)Less than 10% difference or 3 mg/dL difference (for low level).No significant interference up to 1,500 mg/dL.Analytical Performance
    Interferences (Drugs)No interference at three-times therapeutic levels.No interference found for listed drugs.Analytical Performance
    Matrix Equivalence (Correlation Coefficient)Close to 1.00.Serum (SST): 1.00; Plasma (K2 EDTA): 1.00; Plasma (Lithium Heparin): 1.00.Analytical Performance
    Matrix Equivalence (Slope)Close to 1.00.Serum (SST): 1.00; Plasma (K2 EDTA): 0.96; Plasma (Lithium Heparin): 0.99.Analytical Performance
    Matrix Equivalence (Intercept)Close to 0.Serum (SST): +0.1; Plasma (K2 EDTA): -0.1; Plasma (Lithium Heparin): -0.4.Analytical Performance
    Clinical Association with CHDDemonstrates predictive value for incident CHD, and validates clinical cutoff.sd LDL-C predicted future CHD events. Cutoff of 50.0 mg/dL was validated (HR 1.26 in fully adjusted model, p=0.0006 for sd LDL-C >= 50 mg/dL vs
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