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510(k) Data Aggregation

    K Number
    K091741
    Device Name
    TINA-QUANT CERULOPLASMIN
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2010-03-18

    (275 days)

    Product Code
    CHN
    Regulation Number
    866.5210
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K062114
    Why did this record match?
    Device Name :

    TINA-QUANT CERULOPLASMIN

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

    Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.

    Device Description

    The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ceruloplasmin Assay, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance Criteria CategorySpecific CriterionCriteria Value / ThresholdReported Device PerformanceStudy Type to Demonstrate Performance (Implicit)
    Precision (Repeatability)Control LowSD ≤ 0.4 mg/dL; CV ≤ 1.5%SD 0.4 mg/dL; CV 1.5%Internal Verification
    Control HighSD ≤ 0.9 mg/dL; CV ≤ 0.9%SD 0.9 mg/dL; CV 0.9%Internal Verification
    Serum LowSD ≤ 1.2 mg/dL, CV ≤ 1.2%SD 1.2 mg/dL, CV 1.2%Internal Verification
    Serum MediumSD ≤ 0.5 mg/dL, CV ≤ 0.8%SD 0.5 mg/dL, CV 0.8%Internal Verification
    Serum HighSD ≤ 0.9 mg/dL, CV ≤ 0.8%SD 0.9 mg/dL, CV 0.8%Internal Verification
    Precision (Intermediate/Total)Control LowSD ≤ 0.4 mg/dL; CV ≤ 1.6%SD 0.4 mg/dL; CV 1.6%Internal Verification
    Control HighSD ≤ 0.7 mg/dL; CV ≤ 1.1%SD 0.7 mg/dL; CV 1.1%Internal Verification
    Serum LowSD ≤ 0.4 mg/dL, CV ≤ 1.6%SD 0.4 mg/dL, CV 1.6%Internal Verification
    Serum MediumSD ≤ 0.7 mg/dL, CV ≤ 1.0%SD 0.7 mg/dL, CV 1.0%Internal Verification
    Serum HighSD ≤ 1.1 mg/dL, CV ≤ 0.9%SD 1.1 mg/dL, CV 0.9%Internal Verification
    Analytical SensitivityLimit of Blank (LoB)≤ 2 mg/dL≤ 2 mg/dLInternal Verification
    Limit of Detection (LoD)≤ 3 mg/dL≤ 3 mg/dLInternal Verification
    Analytical SpecificityInterference (Common Drugs)No interference at common therapeutic concentrationsNo interference was found at common therapeutic concentrations using common drug panels.Interference Study
    Interferences (Recovery)IcterusRecovery within ±10% up to I-index 60No significant interference up to an I index of 60 (approx. 60 mg/dL conjugated/unconjugated bilirubin)Interference Study
    HemolysisRecovery within ±10% up to H-index 350No significant interference up to an H index of 350 (approx. 350 mg/dL hemoglobin)Interference Study
    LipemiaRecovery within ±10% up to L-index 400No significant interference up to an L Index of 400 mg/dL.Interference Study
    Rheumatoid Factor (RF)No interference up to RF
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