LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052017
    Device Name
    CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2005-09-01

    (37 days)

    Product Code
    MKW
    Regulation Number
    862.1235
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

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

    The Cyclosporine CSAE Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

    Device Description

    The Dimension® CSAE Cyclosporine Flex® reagent cartridge (DF108) is an in vitro rine Differences that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination cyclosporine A (CSA) in human whole blood.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Dimension® Cyclosporine CSAE Flex® reagent cartridge, focusing on acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria for most performance characteristics. Instead, it reports the performance values observed during the studies. For linearity and functional sensitivity, implicit criteria can be inferred.

    Performance CharacteristicAcceptance Criteria (Implicit/Inferred)Reported Device Performance
    ReproducibilityNot explicitly statedWhole Blood Pool 1:
    Repeatability SD: 12.21 (3.32%CV)
    Within-lab SD: 19.00 (5.16%CV)
    Whole Blood Pool 2:
    Repeatability SD: 30.65 (2.73%CV)
    Within-lab SD: 57.24 (5.10%CV)
    Whole Blood Pool 3:
    Repeatability SD: 46.72 (2.64%CV)
    Within-lab SD: 104.07 (5.29%CV)
    More Control 1:
    Repeatability SD: 13.99 (2.86%CV)
    Within-lab SD: 28.77 (5.89%CV)
    More Control 2:
    Repeatability SD: 18.61 (2.15%CV)
    Within-lab SD: 47.71 (5.51%CV)
    More Control 3:
    Repeatability SD: 34.41 (2.64%CV)
    Within-lab SD: 68.89 (5.29%CV)
    Method ComparisonNot explicitly stated (Implicit: good correlation with predicate and LC/MS)vs. Abbott TDx® (All):
    Slope: 1.13
    Intercept: -67.2
    Correlation Coefficient: 0.980
    vs. LCMS (All):
    Slope: 1.09
    Intercept: 17.1
    Correlation Coefficient: 0.986
    LinearityDeviation from estimated line
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1