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510(k) Data Aggregation

    K Number
    K040508
    Device Name
    VITALAB MAGNESIUM REAGENT
    Manufacturer
    CLINICAL DATA, INC.
    Date Cleared
    2004-03-08

    (10 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITALAB MAGNESIUM REAGENT

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

    The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).

    Device Description

    The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Vitalab Magnesium Reagent, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Linear Range0.1 to at least 5.0 mg/dL
    (Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55
    Detection Limit0.1 mg/dL (calculated as mean + 2 standard deviations from 30 assays of normal saline, rounded up)
    PrecisionSerum 1 (1.2 mg/dL): Within Run 1SD = 0.03, %CV = 2.2%; Total 1SD = 0.4, %CV = 3.2%
    Serum 2 (2.2 mg/dL): Within Run 1SD = 0.02, %CV = 0.8%; Total 1SD = 0.3, %CV = 1.1%
    Serum 3 (3.3 mg/dL): Within Run 1SD = 0.02, %CV = 0.7%; Total 1SD = 0.3, %CV = 1.0%
    CorrelationSelectra = 0.3 mg/dL + 0.889 x Competitive Reagent, syx = 0.04 mg/dL (range = 1.5 - 5.2 mg/dL, n = 118)
    Stability14-day onboard reagent stability (total imprecision
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