LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060264
    Device Name
    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-03-08

    (35 days)

    Product Code
    JIY
    Regulation Number
    862.1410
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K944093
    Why did this record match?
    Device Name :

    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

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

    The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

    Device Description

    The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device 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 of iron in serum and plasma.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    Performance CharacteristicAcceptance Criteria (Implied/Direct)Reported Device Performance
    Precision/ReproducibilityBased on CLSI/NCCLS EP5-A2 guideline. Specific CV% targets are implied by showing results within acceptable clinical ranges.Repeatability (%CV):
    Plasma pool: 0.5%
    Serum pool 1: 0.5%
    Serum pool 2: 0.5%
    Serum pool 3: 0.5%
    BioRad Lyphochek® control Level 1: 0.5%
    BioRad Lyphochek® control Level 2: 1.1%
    BioRad Lyphochek® Anemia control Level 1: 1.3%
    Reduced Sample Volume Serum pool 1: 0.6%
    Reduced Sample Volume Serum pool 2: 0.5%
    Reduced Sample Volume Serum pool 3: 0.5%
    Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.3%
    Reduced Sample Volume BioRad Multiqual® control Level 3: 0.7%

    Within-lab Standard Deviation (%CV):
    Plasma pool: 0.7%
    Serum pool 1: 0.6%
    Serum pool 2: 1.1%
    Serum pool 3: 0.8%
    BioRad Lyphochek® control Level 1: 0.7%
    BioRad Lyphochek® control Level 2: 1.9%
    BioRad Lyphochek® Anemia control Level 1: 1.9%
    Reduced Sample Volume Serum pool 1: 0.9%
    Reduced Sample Volume Serum pool 2: 1.1%
    Reduced Sample Volume Serum pool 3: 0.8%
    Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.9%
    Reduced Sample Volume BioRad Multiqual® control Level 3: 0.9% |
    | Linearity/Assay Reportable Range | Correlation coefficient of 0.999, slope of 0.999, and intercept of 0.178. Assay range claim: 5.0 µg/dL to 1000 µg/dL. | Correlation Coefficient: 0.999
    Slope: 0.999
    Intercept: 0.178
    Assay Range Claim: 5.0 µg/dL to 1000 µg/dL |
    | Detection Limit (Analytical Sensitivity) | Ability to distinguish iron from zero. | Analytical Sensitivity: 5 µg/dL [0.9 µmol/L] |
    | Analytical Specificity (Interference) | Systematic inaccuracies (bias) due to interfering substances

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1