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510(k) Data Aggregation

    K Number
    K170678
    Device Name
    Beta-CrossLaps CalCheck 5
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2017-04-04

    (29 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 :

    Beta-CrossLaps CalCheck 5

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

    This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.

    Device Description

    The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.

    AI/ML Overview

    The provided document describes the ß-CrossLaps CalCheck 5, a quality control material intended for calibration verification and assay range verification on cobas e immunoassay analyzers.

    Here's an analysis of the acceptance criteria and the studies performed:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Study/ParameterAcceptance CriteriaReported Device Performance (as per studies presented)
    Value AssignmentAssigned range for Levels 2-5: ±27% of the assigned value.
    Target Value for Check 1: ≤0.05 ng/mLThe CalChecks are run in duplicate on at least two (2) modules (each with two measuring cells) of the cobas e 801 with at least two runs. The assigned value is the median of at least six (6) determinations. The acceptance criterion for the assigned range is applied.
    Open Vial StabilityCalCheck Level 1:
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