LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

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
    Predicate For
    N/A
    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 < 76 IU/mL (highest tested)Rheumatoid factors <76 IU/mL do not interfere.Interference Study
    High-Dose Hook EffectNo Hook EffectUp to 500 mg/dL ceruloplasminNo high-dose hook effect was found up to ceruloplasmin concentrations of 500 mg/dL.Internal Verification
    Method ComparisonCorrelation with predicate devicey = 1.02x + 0.302 (Passing Bablock); $\tau$ = 0.934 y = 0.980x - 0.411 (Linear Regression); r = 0.997Passing Bablock: y = 1.02x + .302; $\tau$ = 0.934 Linear Regression: y = 0.980x - 0.411; r = 0.997Method Comparison Study

    Study Information

    Here's the detailed study information based on the provided text, recognizing that this is a 510(k) summary for an in vitro diagnostic (IVD) assay, which typically focuses on analytical performance rather than clinical endpoints or interpretation by human readers.

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

      • Precision Studies (Repeatability and Intermediate Precision):
        • Test set size: Not explicitly stated as a single "test set" size. The data for precision studies are typically derived from replicate measurements of control materials and human serum samples. The text lists values for "Control Low," "Control High," "Serum Low," "Serum Medium," and "Serum High." The number of replicates or days over which these were run is not detailed in the provided summary.
        • Data provenance: Not specified, but generally, analytical validation studies for IVDs use samples from various sources to ensure broad applicability. Likely internal lab data.
      • Analytical Sensitivity (LoB, LoD):
        • Test set size: Not specified. These are determined through statistical methods based on multiple measurements of blank samples and low-level analyte samples.
        • Data provenance: Not specified. Likely internal lab data.
      • Analytical Specificity/Interferences:
        • Test set size: Not specified for each interference substance, but implies various concentrations of bilirubin, hemoglobin, intralipid, and rheumatoid factor were tested.
        • Data provenance: Not specified. Likely internal lab data and commercially available panels.
      • Method Comparison Study:
        • Test set size: n = 82 samples.
        • Data provenance: Not specified (e.g., country of origin). The study involved "samples concentrations were between 13.2 and 132.1 mg/dL," suggesting human serum/plasma samples. It's a retrospective comparison against the predicate device.

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

      • This question is not applicable to this type of device and study. The "ground truth" for an IVD diagnostic assay's analytical performance is the true concentration of the analyte (ceruloplasmin) in a sample, determined by a reference method or known concentration in control materials. It does not involve expert interpretation or consensus.

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

      • This question is not applicable to this type of device and study. Adjudication methods are relevant for studies involving human interpretation (e.g., imaging studies) where disagreements among readers need resolution. For an analytical assay, the "result" is a quantitative value.

    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:

      • This question is not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that aids human readers. The study compares the new assay's performance to a predicate device, not human performance with/without AI.

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

      • Yes, implicitly. The Tina-quant Ceruloplasmin Assay is a fully automated immunoturbidimetric assay on Roche automated clinical chemistry analyzers. Its performance is measured independently of human interpretation of the assay result. Humans operate the analyzer and interpret the quantitative output in a clinical context, but the assay itself is standalone in generating the ceruloplasmin concentration.

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

      • For precision and analytical sensitivity/specificity, the "ground truth" generally refers to:
        • Known concentrations in control materials: For controls with assigned ceruloplasmin values.
        • Reference measurement procedures: For spiked samples or characterized serum pools where the true ceruloplasmin concentration is established by a highly accurate method.
      • For interferences, the ground truth is the expected recovery of ceruloplasmin in the presence of interferents, with the baseline ceruloplasmin value serving as the reference.
      • For the method comparison study, the "ground truth" for evaluating the new device's accuracy is the results obtained from the predicate device (Roche Ceruloplasmin assay on cobas c510). This is a common approach for demonstrating substantial equivalence for IVDs.

    7. The sample size for the training set:

      • This information is not provided in the 510(k) summary. For an immunoturbidimetric assay like this, there isn't a "training set" in the sense of machine learning. The assay's parameters (e.g., reagent concentrations, reaction times) are developed and optimized internally by the manufacturer through R&D, not through an explicit "training set" of patient data.

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

      • Since there isn't a "training set" in the machine learning sense, this question is not applicable. The underlying method for establishing the analytical accuracy of instruments or assays relies on reference materials and reference methods. The device is standardized against the reference preparation CRM 470 (RPPHS - Reference Preparation for Proteins in Human Serum), which serves as a fundamental aspect of establishing accuracy and traceability.
    Ask a Question

    Ask a specific question about this device

    K Number
    K063655
    Device Name
    DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2007-02-15

    (69 days)

    Product Code
    CHN,JIX,JJY
    Regulation Number
    866.5210
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K053074,K012470,K012468
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dimension Vista™ CER Flex® reagent cartridge: The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

    Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.

    Dimension Vista" Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.

    Device Description

    Dimension Vista™ CER Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

    Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

    Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

    AI/ML Overview

    1. Acceptance Criteria and Reported Device Performance:

    The primary acceptance criteria for the Dimension Vista™ CER assay are based on demonstratincorr correlation and equivalent performance with the predicate device (Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System). While explicit numerical thresholds for acceptance (e.g., minimum correlation coefficient, maximum acceptable slope/intercept deviation) are not provided, the reported performance is presented to demonstrate that these criteria have been met.

    MetricAcceptance Criteria (Implied)Reported Device Performance
    Correlation CoefficientHigh correlation with predicate system (N Antisera on BN ProSpec®)0.994
    SlopeClose to 1.0 (relative to predicate system)1.009
    Intercept (g/L)Close to 0.0 (relative to predicate system)0.008

    2. Sample Size and Data Provenance:

    • Test Set Sample Size: 130 samples.
    • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "evaluating serum and plasma samples," implying collection for the purpose of the study, which could suggest prospective, but this is not explicitly confirmed.

    3. Number of Experts and Qualifications for Ground Truth:

    Not applicable. This study involves a direct comparison of a new assay against a legally marketed predicate assay, not against a ground truth established by experts interpreting various forms of data (e.g., images, clinical symptoms). The "ground truth" or reference for comparison is the performance of the predicate device.

    4. Adjudication Method:

    Not applicable. There was no need for adjudication as the study directly compares quantitative assay results from two different systems.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No, an MRMC comparative effectiveness study was not done. This study is a method comparison for an in vitro diagnostic (IVD) assay, not a study evaluating human reader performance with or without AI assistance.

    6. Standalone Performance Study:

    Yes, a standalone performance study was conducted in the sense that the Dimension Vista™ CER assay's performance was directly measured and compared against the predicate device. This is typical for IVD device submissions, where the "standalone" performance refers to the device's output without human interpretation in the results generation process. The comparison is between the Dimension Vista™ CER assay results and the predicate assay results for the same samples.

    7. Type of Ground Truth Used:

    The "ground truth" for this method comparison study is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System. This is a common approach for demonstrating substantial equivalence for new IVD assays.

    8. Sample Size for the Training Set:

    Not applicable. This is a method comparison study for an IVD device, not a machine learning model that requires a "training set." The device is a reagent cartridge and calibrator system for a laboratory instrument, not an AI algorithm learned from data.

    9. How Ground Truth for Training Set was Established:

    Not applicable, as there is no training set for this type of device and study.

    Ask a Question

    Ask a specific question about this device

    K Number
    K062114
    Device Name
    CERULOPLASMIN, MODEL 2055953
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2007-01-31

    (191 days)

    Product Code
    CHN
    Regulation Number
    866.5210
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K954992,K812486
    Predicate For
    K091741
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
    Indications For Use:
    COBAS INTEGRA:
    In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
    Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
    Roche/Hitachi cobas c systems:
    In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
    Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.

    Device Description

    The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992.
    Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
    The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the COBAS INTEGRA Ceruloplasmin device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicPredicate Device (0.06-1.3 g/L)COBAS INTEGRA Ceruloplasmin (Acceptance Criteria/Performance)
    Measuring Range0.06-1.3 g/L0.06-1.26 g/L (Reported performance, implying this is the accepted range for the device)
    Lower Detection Limit0.02 g/L0.017 g/L (Reported performance, implying this is the accepted limit for the device). This is an improvement compared to the predicate device.
    Expected Values0.2-0.6 g/L0.2-0.6 g/L (Same as predicate, implying this is the accepted range for normal values)
    Precision (Within run total CV%)
    At ~0.2-0.27 g/L1.0% @ 0.27 g/L3.88% @ 0.2 g/L (Reported performance)
    At ~0.34-0.35 g/L1.4% @ 0.34 g/L2.66% @ 0.35 g/L (Reported performance)
    At ~0.62 g/L1.6% @ 0.62 g/L(No corresponding data point provided for COBAS INTEGRA Ceruloplasmin)
    Linearity0.06-0.69 g/L0.06-1.26 g/L (Reported performance, implying this is the accepted linear range for the device. This is an improvement compared to the predicate device.)
    Endogenous Interferences
    Hemolysisno interferences up to 10 g/Lno significant interferences (Reported performance, implying this is the accepted level of interference)
    Icterusno interferences up to 600 mg/Lno significant interferences (Reported performance, implying this is the accepted level of interference)
    Triglycerides/Lipemiano interferences up to 25 g/Lno significant interferences (Reported performance, implying this is the accepted level of interference)
    Rheumatoid factors(Not mentioned)no significant interferences up to 400 IU/mL (Reported performance)
    Exogenous Interferences(Not mentioned)Gammopathy, in particular IgM, may cause unreliable results in rare cases (Reported, implying this is an accepted limitation)
    Method Comparison (vs. DakoCytomation Anti Human Ceruloplasmin)y = 1.0x - 0.0 g/L; r = 0.987y = 1.0x - 0.0 g/L; r =0.987 (Reported, implying agreement with the predicate is the accepted criterion)

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

    The document does not explicitly state the sample sizes used for validating each performance characteristic (e.g., precision, linearity, interference studies, or method comparison). The data provenance is not specified regarding country of origin or an explicit retrospective/prospective design. However, the context of a 510(k) submission for a new in vitro diagnostic (IVD) device typically implies prospective testing conducted by the manufacturer, likely at their facilities.

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

    Not applicable. This device is an in vitro diagnostic (IVD) assay for a quantitative biomarker (ceruloplasmin). The "ground truth" for such devices is established by analytical methods and comparison to a predicate device or reference material, not by expert interpretation of images or clinical cases.

    4. Adjudication Method for the Test Set

    Not applicable, as this is an IVD assay, not a device requiring human interpretation and adjudication of results. The method comparison refers to the statistical comparison of results from the new device against the predicate device.

    5. 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

    Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

    Yes, this is an algorithm-only (standalone) performance. The device is a fully automated immunoturbidimetric assay system that quantitatively determines ceruloplasmin levels. There is no human intervention in the result generation process; the result is directly reported by the instrument.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    The ground truth for this device's performance is established through:

    • Reference materials: The device "Standardized against IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) for 14 serum proteins." This reference material serves as a "ground truth" for calibrating the assay.
    • Comparison to a legally marketed predicate device: The method comparison data shows results against the DakoCytomation Polyclonal Rabbit Anti-Human Ceruloplasmin (K812486), which serves as a clinical benchmark (or "ground truth" in terms of clinical performance equivalence).

    8. The Sample Size for the Training Set

    Not explicitly stated. For IVD devices, a "training set" in the context of machine learning is not directly applicable. The "training" here refers to the development and optimization of the reagent formulation and assay parameters. The document doesn't provide specific sample sizes for these development phases.

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

    Not explicitly stated in the document. For IVD assays, the "ground truth" for development and optimization (analogous to training) would typically involve:

    • Using known concentrations of ceruloplasmin (e.g., from purified human ceruloplasmin or spiked samples).
    • Testing against established reference methods or highly characterized samples.
    • Performing extensive analytical verification during the development phase to ensure the assay performs as intended across its measuring range and with various interference challenges.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1