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510(k) Data Aggregation

    K Number
    K994277
    Device Name
    ACCESS OSTASE QC
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2000-01-14

    (25 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCESS OSTASE QC

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

    Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

    Device Description

    The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those acceptance criteria. It primarily focuses on the submission details, regulatory classification, and intended use of the Access Ostase QC device.

    However, based on the general understanding of Quality Control Materials for in vitro diagnostics, I can infer the likely nature of such a study and the potential acceptance criteria, though the specific values are not present in the document.

    Here's a breakdown of what can be extracted and what needs to be inferred for a Quality Control Material like "Access Ostase QC":

    Inferred Acceptance Criteria and Reported Device Performance (as typically expected for QC materials):

    Acceptance Criteria CategoryTypical Acceptance Criteria for QC Material (Inferred)Reported Device Performance (Not found in provided text)
    Accuracy (Trueness)Mean measured value of the QC material falls within a pre-defined range of the target/assigned value (e.g., +/- X% of the target value for each level).Specific mean measured values and their deviation from target values for Level 1 and Level 2 would be reported.
    Precision (Repeatability/Within-Run)Coefficient of Variation (CV%) for replicate measurements of the QC material is below a specified threshold (e.g.,
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