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510(k) Data Aggregation

    K Number
    K070453
    Device Name
    OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
    Manufacturer
    OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
    Date Cleared
    2007-06-11

    (115 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K030740,K002706
    Why did this record match?
    Reference Devices :

    K030740, K002706

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

    System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.

    Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

    Device Description

    In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles

    AI/ML Overview

    The Olympus D-Dimer Test System, consisting of the Olympus D-Dimer Reagent, Calibrator, and Control, is intended for the quantitative determination of D-Dimer in human plasma on Olympus analyzers. It is designed to aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation.

    Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

    1. Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary compares the Olympus D-Dimer Test System with the predicate device, Roche Tina-Quant® D-Dimer Test System. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate, with specific performance characteristics indicating acceptable levels.

    Performance CharacteristicAcceptance Criteria (Implied by Predicate)Reported Olympus D-Dimer Test System Performance
    Precision (Total CV%)Sample 1: 6.5%AU400/400e: 9.44%
    AU600/640/640e: 9.14%
    AU2700/5400: 8.17%
    Sample 2: 8.3%AU400/400e: 7.99%
    AU600/640/640e: 7.95%
    AU2700/5400: 4.44%
    Sample 3: 3.2%AU400/400e: 2.48%
    AU600/640/640e: 3.02%
    AU2700/5400: 2.52%
    Assay Range0.15 - 9.0 µg FEU/mL0.15 - 8.00 µg FEU/mL
    Analytical Sensitivity0.04 µg FEU/mL0.08 µg FEU/mL
    Method ComparisonIntercept: 0.06
    Slope: 0.87
    R2: 0.755
    Range: 0.08-4.55 µg FEU/mLIntercept: 0.079
    Slope: 1.010
    R2: 0.996
    Range: 0.28-7.53 µg FEU/mL
    Interfering SubstancesWithin ±10% variation:
    • Bilirubin up to 20 mg/dL
    • Hemolysis up to 500 mg/dL Hemoglobin
    • Rheumatoid Factor
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