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    K Number
    K083444
    Device Name
    C-REACTIVE PROTEIN (LATEX)
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2009-03-18

    (117 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K032336
    Predicate For
    K161982,K172868,K192072
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
    Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.

    Device Description

    The C-Reactive Protein Gen 3 assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 570 nm.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Tina-Quant C-Reactive Protein Gen. 3 device, based on the provided text:

    Acceptance Criteria and Device Performance

    The provided document describes modifications to an existing device (Tina-Quant C-Reactive Protein Gen 3) and claims substantial equivalence to its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336). Therefore, the acceptance criteria are implicitly defined by demonstrating comparable core performance characteristics to the predicate device. The information below presents the modified device's performance alongside the predicate's performance for comparison, which serves as the "acceptance criteria" through the lens of substantial equivalence.

    Table of Acceptance Criteria (Predicate Performance) and Reported Device Performance (Modified Device)

    FeatureAcceptance Criteria (Predicate Device Performance - K032336)Reported Device Performance (Modified Device - K082444)
    Measuring RangeRoche/Hitachi 902: 1-265 mg/LRoche/Hitachi 717/Modular D: 1-265 mg/L, 1-398 mg/L with rerunRoche/Hitachi 904/911/912: 1-260 mg/L, 1-520 mg/L with rerunRoche/Hitachi 917/Modular P: 1-280 mg/L, 1-560 mg/L with rerunRoche/Hitachi 901/912/917/Modular P/Modular D analyzers: 0.3-350 mg/L. Dilution of samples via the rerun function is a 1:2 dilution.
    Precision (Within Run)Control 1: Mean (mg/L) 3.36, SD (mg/L) 0.09, %CV 2.76Control 2: Mean (mg/L) 22.17, SD (mg/L) 0.44, %CV 1.96Control 3: Mean (mg/L) 51.12, SD (mg/L) 0.90, %CV 1.77H Pool 1: Mean (mg/L) 5.76, SD (mg/L) 0.14, %CV 2.50H Pool 2: Mean (mg/L) 150.15, SD (mg/L) 1.14, %CV 0.76Control 1: Mean (mg/L) 3.6, SD (mg/L) 0.03, %CV 0.85Control 2: Mean (mg/L) 42.2, SD (mg/L) 0.26, %CV 0.61H Pool 1: Mean (mg/L) 0.9, SD (mg/L) 0.03, %CV 4.00H Pool 2: Mean (mg/L) 1.6, SD (mg/L) 0.02, %CV 1.02H Pool 3: Mean (mg/L) 18.4, SD (mg/L) 0.09, %CV 0.48
    Precision (Between Run)Control 1: Mean (mg/L) 3.51, SD (mg/L) 0.16, %CV 4.61Control 2: Mean (mg/L) 22.01, SD (mg/L) 0.62, %CV 2.81Control 3: Mean (mg/L) 50.41, SD (mg/L) 0.94, %CV 1.86H Pool 1: Mean (mg/L) 5.99, SD (mg/L) 0.15, %CV 2.53H Pool 2: Mean (mg/L) 146.31, SD (mg/L) 2.63, %CV 1.80Control 1: Mean (mg/L) 3.1, SD (mg/L) 0.08, %CV 2.7Control 2: Mean (mg/L) 41.4, SD (mg/L) 0.86, %CV 2.1H Pool 1: Mean (mg/L) 0.5, SD (mg/L) 0.03, %CV 6.2H Pool 2: Mean (mg/L) 1.5, SD (mg/L) 0.05, %CV 3.3H Pool 3: Mean (mg/L) 39.1, SD (mg/L) 0.73, %CV 1.9
    Analytical SensitivityFunctional Sensitivity: 0.88 mg/LLower Detection Limit: 0.425 mg/LLimit of Quantitation (Functional Sensitivity): 0.6 mg/LLoB: 0.2 mg/LLoD: 0.3 mg/L
    InterferencesIcterus: No significant interference up to 60 mg/dLHemolysis: No significant interference up to 950 mg/dLLipemia: No significant interference up to L index of 1700Rheumatoid Factor: No interference up to 1200 IU/mLHigh dose hook effect: No false results up to CRP concentrations of 1200 mg/LIcterus: same (implicitly up to 60 mg/dL)Hemolysis: No significant interference up to 1000 mg/dLLipemia: No significant interference up to L index of 1000Rheumatoid Factor: same (implicitly up to 1200 IU/mL)High dose hook effect: same (implicitly up to 1200 mg/L)
    Method ComparisonSlope (Passing Bablok): 1.020Intercept: 0.000Coefficients of correlation (r): 1.000Comparison was performed against Tina-Quant C-Reactive Protein (latex) on Hitachi 917. Specific numerical results (slope, intercept, correlation coefficient) for the modified device against the predicate are not provided in this section, but the predicate's values are listed as the reference, implying the modified device aims to match these.

    Study Information

    The provided document describes a Special 510(k): Device Modification submission for the Tina-Quant C-Reactive Protein Gen 3 assay. The core of the "study" is a comparison of the modified device's performance characteristics against its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336), to demonstrate substantial equivalence.

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

      • Test Set Sample Size: The document does not explicitly state the specific number of samples used for each test (e.g., precision, interference, method comparison). For the "Method Comparison," it refers to a "Scatter plot showing correlation between two methods for measuring C-Reactive Protein," which implies a collection of patient or control samples were run on both methods. However, the exact count is not given.
      • Data Provenance: Not explicitly stated. The studies were conducted by Roche Diagnostics, suggesting internal studies. The country of origin of the data is not mentioned, nor is whether the data was retrospective or prospective.

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

      • This is an in vitro diagnostic (IVD) device for quantitative determination of CRP. For such devices, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by expert consensus on interpretations like with imaging. The document traces the device's standardization to CRM 470, which is a certified reference material for proteins. There is no mention of experts establishing a ground truth in the context of clinical interpretation, as this device provides a quantitative measurement.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable. This is an IVD device for quantitative measurement. Adjudication methods like "2+1" typically apply to diagnostic tasks involving human interpretation or subjective assessments, where disagreements between experts need to be resolved.

    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:

      • No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not a device that assists human readers (like AI for image analysis). Therefore, comparisons of human reader performance with or without AI assistance are not relevant to this submission.

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

      • Yes, effectively, this is a standalone device performance evaluation. The device is an automated clinical chemistry analyzer that quantitatively measures CRP. The performance metrics reported (precision, analytical sensitivity, interference, method comparison) are intrinsic to the device's analytical function without direct human intervention in the result generation process, beyond sample loading and general operation.

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

      • Reference material standardization. The device claims traceability to CRM 470 for standardization. This implies that the "ground truth" for the quantitative CRP measurements is established against this internationally recognized reference material, rather than clinical outcomes, pathology, or expert consensus on a diagnostic interpretation.

    7. The sample size for the training set:

      • Not applicable. This document is for a device modification of an in vitro diagnostic assay, not an AI/ML algorithm. Therefore, there isn't a "training set" in the sense of data used to train a machine learning model. The assay's parameters would have been developed and optimized through laboratory experiments, but the concept of a "training set" as commonly understood in AI/ML is not directly relevant here.

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

      • Not applicable. As explained above, there is no "training set" for an AI/ML algorithm. For the initial development and optimization of the assay reagents and methods, ground truth for measuring CRP would typically be established using highly characterized samples with known CRP concentrations (e.g., purified CRP, reference materials like CRM 470, or validated high-accuracy laboratory methods).
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    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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