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510(k) Data Aggregation

    K Number
    K072658
    Device Name
    ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Date Cleared
    2008-04-01

    (194 days)

    Product Code
    DCN,JIX
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k992662,K022682
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADVIA CHEMISTRY C-Reactive Protein_2 assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements are used in the evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Increases in CRP values are non-specific for many disease processes and should not be interpreted without a complete clinical evaluation.

    The ADVIA Chemistry C-Reactive Protein_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the C-Reactive Protein 2 (CRP 2) method.

    Device Description

    The ADVIA Chemistry C-Reactive Protein_2 (CRP_2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein in human serum and plasma on the ADVIA® Chemistry systems. The ADVIA Chemistry C-Reactive Protein_2 Calibrators are used to calibrate this method. The proposed labeling indicates the ADVIA Chemistry CRP_2 reagents and Calibrators are for use on the family of ADVIA Chemistry Systems (1200 / 1650 / 1800 / 2400).

    The CRP_2 latex reagent is a suspension of uniform polystyrene latex particles coated with rabbit anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in the turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.

    The ADVIA® Chemistry C-Reactive Protein_2 Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted expected values (lot specific) of 0, 5, 20, 40, 160, and 320 mg/L.

    The calibrators (1 mL/vial) and ready to use. Storage is at 2 - 8℃.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:

    This document describes an in vitro diagnostic (IVD) device, specifically an assay and calibrators for measuring C-Reactive Protein (CRP). The acceptance criteria are primarily focused on demonstrating substantial equivalence to existing predicate devices through performance studies.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this IVD device are implicitly defined by demonstrating performance that is comparable to or better than the predicate device across various analytical characteristics.

    Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance Criteria (Implicit for Substantial Equivalence)Reported Device Performance (ADVIA Chemistry C-Reactive Protein_2)
    Imprecision (Total CV)Comparable to or better than predicate deviceADVIA 1650:
    - CRP level 31 mg/L: 1.3%
    - CRP level 56 mg/L: 1.1%
    - CRP level 83 mg/L: 1.5%
    - CRP level 221 mg/L: 1.5%
    Correlation ($r$)Strong correlation (e.g., $r \ge 0.975$) with predicate0.990 (Serum, ADVIA 1650 vs. ADVIA 1650 CRP)
    & Linear RegressionSlope near 1.0, intercept near 0.0$Y = 0.99x - 2.8$
    Analytical RangeMeet specified clinical range and compare to predicate4 to Calibrator 6 (304-336) mg/L on ADVIA 1650
    Interfering SubstancesMinimal clinically significant interferenceHemoglobin (1000 mg/dL): 0.7% change
    (e.g., % change < 10% or within set limits)Lipids (Intralipid 1000 mg/dL): -0.7% change
    Lipids (Triglycerides 1000 mg/dL): 0.5% change
    Bilirubin, free (60 mg/dL): 1.8% change
    Bilirubin, conjugated (60 mg/dL): 2.0% change
    Rheumatoid Factor (200 IU/mL): 8.4% change
    Serum/Plasma EquivalencyTo demonstrate comparability of results between sample typesNot explicitly detailed but mentioned as a performed study. Implies acceptable equivalency.
    Calibrator Stability (Open Vial)To ensure acceptable performance for indicated duration60 days stored @2-8°C (predicate: 28 days)

    Study Details Proving Acceptance Criteria

    The studies conducted are primarily analytical performance studies comparing the new device to its predicate.

    1. Sample Size Used for the Test Set and Data Provenance:

      • Imprecision: Not explicitly stated for the test set, but typical precision studies involve running samples multiple times across several days. The reported values are "Level (mg/L)" and "Total CV (%)", suggesting multiple measurements per sample.
      • Correlation/Method Comparison: N=47 samples were used for the method comparison study (Serum, ADVIA 1650 vs. ADVIA 1650 CRP).
      • Interfering Substances: For each interfering substance, performance was assessed at a CRP concentration of 5 mg/L (for Hemoglobin, Lipids, Bilirubin) or 4 mg/L (for Rheumatoid Factor). The number of replicates or distinct samples tested with interferent is not specified, but typically involves spiked samples.
      • Data Provenance: Not specified, but generally for IVD devices, samples are sourced from clinical laboratories or biobanks, representing a relevant patient population. These are typically retrospective samples or spiked samples for analytical studies.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

      • For IVD assays measuring biomarkers like CRP, the "ground truth" is typically established by measurement against a reference method or a validated, widely accepted existing method (the predicate device in this case), rather than expert consensus on diagnostic images or clinical cases. Therefore, experts are not used in the traditional sense to establish individual sample ground truth. The "expertise" lies in the validation of the chosen reference method and the analytical methodologies themselves, overseen by scientific and clinical personnel.

    3. Adjudication Method for the Test Set:

      • None in the context of expert adjudication for clinical cases. As mentioned above, for biomarker assays, the "truth" for a sample's concentration is determined by the reference method.

    4. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done:

      • No. MRMC studies are relevant for devices where human interpretation is involved (e.g., radiology AI). This is an in vitro diagnostic assay where a machine quantitatively measures a biological marker. There is no human interpretative component in the performance evaluation described.

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

      • Yes, this entire submission effectively describes a standalone performance evaluation. The device (ADVIA Chemistry C-Reactive Protein_2 assay) is an automated system that measures CRP concentration. Its performance characteristics (imprecision, correlation, interference, analytical range) are evaluated directly, without human intervention in the measurement process (other than sample preparation and loading). The comparison is between two automated systems (new device vs. predicate device).

    6. The Type of Ground Truth Used:

      • The ground truth for the analytical studies is based on:
        • Measurements from the legally marketed predicate device (ADVIA Chemistry C-Reactive Protein assay, K992662) for method comparison studies.
        • Known concentrations for spiked samples in imprecision and interference studies.
        • Standardization against CRM-470 (a certified reference material), indicating traceability to a recognized international standard for CRP. This reference material effectively establishes the "true" concentration values for calibration and control materials.

    7. The Sample Size for the Training Set:

      • The document does not detail a "training set" in the context of machine learning model development. For IVD assays, "training" typically refers to the process of calibration to establish the relationship between instrument signal and analyte concentration. Calibration is performed using the ADVIA Chemistry C-Reactive Protein_2 Calibrators. These calibrators consist of six levels (0, 5, 20, 40, 160, and 320 mg/L) of recombinant human CRP. The specific number of times or ways these calibrators were run for the development of the assay is not specified in this summary, but the six levels constitute the basis for the calibration curve.

    8. How the Ground Truth for the Training Set was Established:

      • The ground truth for the calibrators (which serve as the "training set" for the instrument's measurement) is established by:
        • Using recombinant human CRP at specific, manufactured concentrations.
        • Standardization to CRM-470, meaning the lot-specific expected values of the calibrators are traceable to this international reference material for CRP. This ensures the accuracy and consistency of the assigned values across different lots and manufacturers.
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