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510(k) Data Aggregation

    K Number
    K973369
    Device Name
    ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1997-11-21

    (74 days)

    Product Code
    LBR,JIS
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K971902
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic device intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.

    Device Description

    The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. UNIMATE HDL Direct is intended for use in clinical and physician's office laboratories (POL) on COBAS MIRA systems. Determination of HDL cholesterol is useful for early detection of an increased risk of atherosclerosis. The principle of the Roche UNIMATE HDL Direct reagent is based on the absorbance of synthetic polymers and polyanions to the surface of lipoproteins. LDL, VLDL, and chylomicrons are transformed into a detergent-resistant form, whereas HDL is not. Combined actions of polymers, polyanions and detergent solubilizes cholesterol from HDL, but not from LDL, VLDL, and chylomicrons. Solubilized cholesterol is oxidized by the sequential enzymatic action of cholesterol esterase and cholesterol oxidase. The H,O, produced in this reaction is reacted with chromogens to form a colored dye. The increase in absorbance at 550 nm is directly proportional to the HDL cholesterol concentration of the sample.

    AI/ML Overview

    The document describes the Roche UNIMATE HDL Direct reagent, an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum, specifically for use in physician's office laboratories (POLs).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a single consolidated table. However, it implicitly uses the National Cholesterol Education Program (NCEP) goals for precision as an acceptance criterion for within-run and total precision, and correlation coefficients for agreement between methods.

    Acceptance Criterion (Implicit)Reported Device Performance
    Correlation (Roche UNIMATE HDL Direct POL vs. RDS Reference)Across three POL sites: Site #1: r = 0.990; Site #2: r = 0.994; Site #3: r = 0.991 (all indicating strong correlation). Linear Regression also provided, showing minimal bias.
    Correlation (POL Usual Method vs. UNIMATE HDL Direct)Across three POL sites: Site #1: r = 0.965; Site #2: r = 0.986; Site #3: r = 0.944 (all indicating strong correlation, though slightly lower than internal comparison). Linear Regression also provided.
    Within-run PrecisionPerformed on three serum pools and Roche N and P controls. Not explicitly stated in tabular form, but the text indicates: "Each POL site achieved the NCEP goals of CVs ≤ 6% at ≥ 42 mg/dL, and SDs of ≤ 2.50 mg/dL at
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