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510(k) Data Aggregation

    K Number
    K053603
    Device Name
    C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-02-09

    (48 days)

    Product Code
    NQD
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K042485,K033908
    Predicate For
    K180099
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.

    Device Description

    The CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the quantitative measurement of C-reactive protein in human serum or plasma. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically. The calibrator is the Calibrator for automated systems (C.f.a.s). Proteins; and the recommended control materials are CRP T Control N and Precinorm Protein.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the C-Reactive Protein (Latex) High Sensitive Test System, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary presents a comparison study to predicate devices rather than explicit acceptance criteria with pre-defined thresholds. The device aims to demonstrate "substantial equivalence" to the predicate devices. Therefore, the "acceptance criteria" here are implied to be performance characteristics that are comparable to or better than the predicate devices.

    CharacteristicPredicate Device (Tina-Quant® CRP (Latex) HS (K042485)) Reported PerformancePredicate Device (Dade-Behring N High Sensitivity CRP (K033908)) Reported PerformanceNew Device (CRP (Latex) HS for COBAS Integra instruments) Reported PerformanceImplied Acceptance Criteria (Demonstrate equivalence/comparability)
    Intended UseQuantitative determination of CRP in human serum/plasma for inflammatory/infection/tissue injury, and aid in CHD risk assessment.Quantitative determination of CRP in human serum/heparin/EDTA plasma using immunonephelometry for infection/tissue injury/inflammatory disorders, and aid in CVD risk assessment. Also independent marker for recurrent events in stable CAD or ACS.Same as K042485Same intended use as predicate devices.
    Assay PrincipleLatex particle-enhanced immunoturbidimetric testParticle-enhanced agglutination with nephelometric detectionSame as K042485 (Latex particle-enhanced immunoturbidimetric test)Consistent assay principle with a predicate (K042485 in this case).
    InstrumentRoche/Hitachi family of analyzersDade-Behring BN Systems (nephelometric systems)COBAS Integra family of analyzers (Integra 400/ 700/ 800)Compatible with specified COBAS Integra instruments.
    Reagent StabilityUnopened: up to expiration date at 2-8 °C. On board: 90 days.Unopened: up to expiration date at 2-8 °C. Opened: 4 weeks in closed vial.Unopened: up to expiration date at 2-8 °C. On board: 12 weeks.Comparable or improved reagent stability.
    Reagent CompositionR1: TRIS buffer, BSA, immunoglobulins (mouse), preservative, stabilizers. R2: Latex particles coated with anti-CRP (mouse) in glycine buffer, preservatives, stabilizers.Suspension of polystyrene particles coated with mouse monoclonal antibodies to CRP; preservatives.Same active ingredients and antibody as K042485Similar reagent components to a predicate.
    Sample TypeHuman serum and plasmaHuman serum, and heparin and EDTA plasmaSame as K042485 (Human serum and plasma)Compatible with human serum and plasma.
    Traceability/StandardizationIFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)Standardized to Tina-Quant® CRP (Latex) HS which is standardized to reference prep CRM 470 (RPPHS 91/0619)Standardized to recognized reference material.
    Measuring Range0.1 – 20 mg/L without dilution. 0.1 – 300 mg/L with dilution and rerun.0.175 – 1100 mg/L with dilution0-20 mg/L without dilution. 0-300 mg/L with postdilution.Comparable or improved measuring range.
    Lower Detection Limit0.03 mg/L0.175 mg/L0.1 mg/LComparable or improved lower detection limit.
    Within-run Precision (%CV)Control: 0.43% at 4.27 mg/L, 0.41% at 11.62 mg/L. Serum: 1.34% at 0.55 mg/L, 0.28% at 12.36 mg/L.Control: 2.5% at 0.5 mg/L, 3.8% at 1.3 mg/L, 2.1% at 2.1 mg/L, 2.6% at 14 mg/L, 3.9% at 24 mg/L, 5.7% at 56 mg/L.Control: 0.9% at 3.3 mg/L, 0.7% at 8.0 mg/L. Serum: 1.3% at 1.6 mg/L, 0.6% at 11.4 mg/L.Comparable or improved within-run precision.
    Between-run Precision (%CV)Control: 2.70% at 4.34 mg/L, 3.45% at 11.90 mg/L. Serum: 5.70% at 0.52 mg/L, 2.51% at 10.98 mg/L.Control: 3.1% at 0.5 mg/L, 3.8% at 1.1 mg/L, 3.4% at 2.1 mg/L, 4.0% at 15 mg/L, 2.3% at 26 mg/L, 4.4% at 62 mg/L.Control: 3.5% at 3.3 mg/L, 2.2% at 8.0 mg/L. Serum: 3.1% at 1.5 mg/L, 2.3% at 11.4 mg/L.Comparable or improved between-run precision.
    Functional Sensitivity (CV <10%)0.11 mg/LNot available.0.3 mg/LComparable functional sensitivity.
    Limitations: InterferencesBilirubin (I index 60), Hemoglobin (H index 1000), Lipemia (L index 1000 at CRP > 5mg/L), Rheumatoid factors < 1200 IU/mL, no high dose hook effect up to 1000 mg/L. Rare cases of gammopathy.Bilirubin up to 230 mg/L, Hemoglobin up to 36 g/L, Triglycerides up to 7.4 g/L. No highly lipemic samples that cannot be clarified.Bilirubin 10 g/L, Hemoglobin 0.6 g/L, Triglyceride 5 g/L at 2 mg/L CRP, Rheumatoid factors < 1200 IU/mL. No high dose hook effect up to 1000 mg/L CRP. Rare cases of monoclonal gammopathy. Erroneous results may be obtained in samples from patients treated with monoclonal mouse.Similar or improved interference profiles to predicate devices.
    Method Comparison(Predicate vs. Predicate)(Predicate vs. Predicate)y = Integra CRP (Latex) hs vs. x = Tina-Quant® CRP (latex) hs. Passing-Bablok results: y=1.0548x + 0.0424. T = 0.956; r = 0.996.Strong correlation and close agreement with predicate device (Tina-Quant®).

    Study Proving Device Meets Acceptance Criteria:

    The study conducted is a method comparison study with a focus on analytical validation experiments.

    • Description of Study: The submission states that "analytical validation experiments were performed in order to establish the performance characteristics" and that "method comparison was performed between this method and the predicate device." The primary predicate for comparison was the Roche Tina-quant® CRP (latex) HS Test System (K042485) and for cardiac risk assessment, the Dade Behring N High Sensitivity CRP (K033908).

    • Key Findings: The new device (CRP (Latex) HS for COBAS Integra instruments) demonstrated:

      • Substantially equivalent intended use, assay principle, reagent composition, sample type, and traceability/standardization to the Tina-Quant® predicate device.
      • Comparable or improved performance characteristics in terms of measuring range, lower detection limit, precision (within-run and between-run), and non-interference levels compared to the predicate devices.
      • A strong correlation in a method comparison against the Tina-Quant® CRP (latex) HS predicate, with Passing-Bablok results showing y = 1.0548x + 0.0424, T = 0.956, and r = 0.996. This indicates excellent agreement and substantial equivalence.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: The exact number of individual patient samples used in the method comparison and analytical validation studies is not explicitly stated in the provided summary. However, for precision studies, control materials and human serum samples were used.
    • Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied to be laboratory-based analytical validation data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • The ground truth for this type of in vitro diagnostic device (quantitative measurement of C-reactive protein) is established by the measured values from the predicate device(s) or recognized reference materials/methods, not through expert visual interpretation. Therefore, a specific number of experts for ground truth establishment is not applicable in the context of this 510(k) summary. The comparison is against established commercial assays.

    4. Adjudication Method for the Test Set

    • Not applicable. As the ground truth is based on quantitative measurements from predicate devices/reference methods, an adjudication method for reconciling expert opinions is not relevant.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

    • No. This is an in-vitro diagnostic device for quantitative measurement, not an imaging device or a diagnostic aid requiring human interpretation of cases. Therefore, an MRMC study is not relevant or performed.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

    • Yes, implicitly. The device is a fully automated test system (immunoturbidimetric assay on automated clinical chemistry analyzers). Its performance characteristics (precision, measuring range, detection limit, interference) and method comparison results are indicative of its standalone performance without human intervention in the measurement process itself. Human involvement is limited to sample loading, result interpretation in a clinical context, and maintenance, not in the determination of the CRP value by the device.

    7. The Type of Ground Truth Used

    • The ground truth is established by quantitative measurements obtained from legally marketed predicate devices (Roche Tina-quant® CRP (latex) HS (K042485) and Dade Behring N High Sensitivity CRP (K033908)), which are themselves standardized to international reference preparation CRM 470 (RPPHS 91/0619).

    8. The Sample Size for the Training Set

    • The document describes a 510(k) submission for a new device, which focuses on demonstrating substantial equivalence to pre-existing predicate devices. It does not explicitly mention a "training set" in the context of machine learning. For an IVD like this, development typically involves internal analytical studies, not a "training set" in the AI sense.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As noted above, the concept of a "training set" for AI models is not directly relevant to this type of IVD device submission, which relies on analytical performance validation against established methods and standards.
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