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510(k) Data Aggregation

    K Number
    K982469
    Device Name
    HICHEM CHOLESTEROL REAGENT KIT
    Manufacturer
    ELAN PHARMA, INC.
    Date Cleared
    1998-08-19

    (35 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

    Device Description

    The HiChem Cholesterol Reagent determines cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase. The resulting increase in absorbance at one of interested estable concessed on concentration in the sample.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the studies performed for the HiChem Cholesterol Reagent, based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document describes two scenarios: the HiChem Cholesterol Reagent as a manual procedure and the HiChem Cholesterol Reagent used as a secondary reagent on Beckman® SYNCHRON CX® Systems. The acceptance criteria are largely implied by the reported performance figures, as specific pre-defined thresholds aren't explicitly stated as "acceptance criteria." However, the comparisons to the predicate device and specified ranges (e.g., linearity) serve as the de facto criteria.

    Scenario 1: HiChem Cholesterol Reagent (Manual Procedure)

    MetricAcceptance Criteria (Implied)Reported Device Performance
    LinearityPerformance should be linear from 5 mg/dL to 750 mg/dL.Linear from 5 mg/dL to 750 mg/dL.
    Regression: (HiChem Recoveries) = 3.7 mg/dL + 0.975 × (Standard Factors), r² = 1.000 Sv.x = 4.11 mg/dL. df = 11
    Precision (Within-run)Not explicitly stated, but expected to be low for control sera.Serum control 1 (109 mg/dL): 0.85 mg/dL
    Serum control 2 (226 mg/dL): 1.46 mg/dL
    Serum control 3 (501 mg/dL): 3.12 mg/dL
    Precision (Total)Not explicitly stated, but expected to be low for control sera.Serum control 1 (109 mg/dL): 0.92 mg/dL
    Serum control 2 (226 mg/dL): 1.90 mg/dL
    Serum control 3 (501 mg/dL): 4.47 mg/dL
    Method ComparisonResults should be equivalent to the Beckman® Cholesterol Reagent.(HiChem Results) = 12 mg/dL + 0.957 × (Beckman® Results)
    r² = 0.966 S(y.x) = 8.1
    Anticoagulant InterferenceBias due to additives should be minimal.Bias
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