LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031042
    Device Name
    ATAC HEMOGLOBIN A1C REAGENT KIT
    Manufacturer
    CLINICAL DATA, INC.
    Date Cleared
    2003-11-03

    (216 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATAC HEMOGLOBIN A1C REAGENT KIT

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

    The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes.

    This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

    Device Description

    The ATAC HemoglobinAlC Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.

    AI/ML Overview

    The provided text describes the ATAC HemoglobinA1C Reagent Kit and studies performed to demonstrate its effectiveness. Here's an analysis based on your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The text doesn't explicitly state "acceptance criteria" for precision or method comparison in a pass/fail format. Instead, it presents the results of these studies. The "acceptance criteria" are implied by the performance statistics themselves, specifically that the results fall within generally accepted ranges for such assays or are comparable to the predicate device.

    Study TypeAcceptance Criteria (Implied)Reported Device Performance
    Precision%CV values within acceptable limits for HbA1c assays.Control 1: %CV (Within Run) = 3.38%, %CV (Total) = 4.74%
    Control 2: %CV (Within Run) = 2.46%, %CV (Total) = 3.08%
    Patient: %CV (Within Run) = 2.60%, %CV (Total) = 4.66%
    Method ComparisonStrong linear correlation and agreement with a comparative method (TOSOH HPLC). Slope close to 1, intercept close to 0.ATAC 8000 = 0.6367 + 0.9722 x Comparative Method
    Calibration StabilityTotal imprecision of %HemoglobinA1C recoveries over claimed period
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1