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510(k) Data Aggregation

    K Number
    K040631
    Device Name
    VITALAB DIRECT BILIRUBIN REAGENT
    Manufacturer
    CLINICAL DATA, INC.
    Date Cleared
    2004-03-18

    (8 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITALAB DIRECT BILIRUBIN REAGENT

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

    The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

    The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

    The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.

    Device Description

    The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.

    The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.

    The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.

    AI/ML Overview

    Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricVitalab Direct Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit)Vitalab Direct Bilirubin Reagent Reported PerformanceVitalab Total Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit)Vitalab Total Bilirubin Reagent Reported Performance
    Linearity/Usable RangeSufficiently linear to meet clinical needs (implicit, typically based on predicate).Linear to at least 10.0 mg/dL.Sufficiently linear to meet clinical needs (implicit, typically based on predicate).Linear to at least 25.0 mg/dL.
    Detection LimitLow enough for clinical utility (implicit).0.0 mg/dL.Low enough for clinical utility (implicit).0.0 mg/dL.
    PrecisionAcceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines).Serum 1 (0.3 mg/dL): Within Run 1SD = 0.03, %CV = 11.3%; Total 1SD = 0.03, %CV = 11.4%.
    Serum 2 (1.7 mg/dL): Within Run 1SD = 0.02, %CV = 1.3%; Total 1SD = 0.05, %CV = 2.8%.
    Serum 3 (4.0 mg/dL): Within Run 1SD = 0.02, %CV = 0.5%; Total 1SD = 0.10, %CV = 2.6%.Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines).Serum 1 (0.4 mg/dL): Within Run 1SD = 0.02, %CV = 5.8%; Total 1SD = 0.03, %CV = 6.7%.
    Serum 2 (1.4 mg/dL): Within Run 1SD = 0.04, %CV = 3.1%; Total 1SD = 0.07, %CV = 4.8%.
    Serum 3 (5.8 mg/dL): Within Run 1SD = 0.07, %CV = 1.1%; Total 1SD = 0.15, %CV = 2.5%.
    Correlation/Method ComparisonSubstantially equivalent to predicate device (implicit standard for 510(k)).Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent (r=0.9995, syx = 0.12 mg/dL if we assume the r and syx from linearity applies to correlation, which is probably incorrect, but no other value given for correlation specific r, syx). Range = 0.1 - 11.6 mg/dL. syx = 0.14 mg/dL (from calibration section, which seems to refer back to this data).Substantially equivalent to predicate device (implicit standard for 510(k)).Selectra = -0.4 mg/dL + 1.037 x Competitive Reagent. Range = 0.1 - 25.9 mg/dL. syx = 0.20 mg/dL.
    Stability (Onboard Reagent & Calibration)Meet claimed stability (implicit).14 day onboard reagent stability and 7 day calibration stability met (total imprecision
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