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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
    Predicate For
    N/A
    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 < 0.1 mg/dL) 7-day calibration stability (total imprecision < 0.1 mg/dL)

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Linear Range: n = 55 (linearity related solutions)
      • Detection Limit: 30 assays of normal saline.
      • Precision: 60 replicate assays for each of the three control serum samples.
      • Correlation: 58 serum specimens (1.5 to 5.2 mg/dL magnesium) and 60 heparinized plasma specimens (1.5 to 2.8 mg/dL magnesium) from adult patients.
      • Stability: Serum controls were used over the claimed periods.
      • Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the studies were conducted by Clinical Data, Inc. (Brea, CA), suggesting the data is likely from the United States. The studies appear to be retrospective observational studies using collected patient specimens and controlled lab samples.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This device is a reagent for an in vitro diagnostic (IVD) assay measuring a quantitative analyte (magnesium). The "ground truth" for such devices is typically established through reference methods, calibration, and highly standardized laboratory procedures, not through expert human interpretation in the same way an imaging or AI diagnostic might be.
      • The document does not mention the use of experts to establish ground truth for the test set beyond standard laboratory practices and reference measurements. Qualifications of individuals performing these reference measurements or calibrations are not provided.

    3. Adjudication method for the test set:

      • Not applicable. This is an IVD reagent, and its performance is evaluated against quantitative measurements and statistical methods, not through human adjudication of diagnostic findings.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not applicable. This is an IVD reagent and does not involve human readers interpreting results in a way that AI assistance would be relevant. The "reader" here is the Vitalab Selectra Analyzer.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • Yes, this is essentially a standalone performance evaluation of the reagent used with the Vitalab Selectra Analyzer. The performance characteristics (linearity, detection limit, precision, correlation, stability) are determined by the reagent and instrument system, independent of direct human interpretive input after the assay is run and before the result is generated.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth for this device is based on reference methods and statistically validated measurements. For linearity, this involves comparing recoveries to standard concentrations. For precision, it involves repeated measurements of control sera with known values. For correlation, it involves comparing results against another commercially available and presumably validated method.

    7. The sample size for the training set:

      • Not applicable. This is an IVD reagent, not a machine learning or AI model that requires a training set in the conventional sense. The "development" of the reagent would involve biochemical formulation and optimization, followed by performance validation, rather than algorithmic training.

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of the reagent system itself is established through analytical validation studies using reference materials and established laboratory practices.
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