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510(k) Data Aggregation

    K Number
    K141827
    Device Name
    EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
    Manufacturer
    EUROIMMUN U.S., Inc.
    Date Cleared
    2015-04-17

    (284 days)

    Product Code
    DHN,PIV
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE

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

    Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel.

    Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semiquantitative determination of IgG antibodies against antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

    Device Description

    The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides.

    AI/ML Overview

    The provided text is a cover letter from the FDA to EUROIMMUN US INC. regarding the 510(k) premarket notification for their EUROIMMUN IFA 40: HEp-20-10 EUROPattern and EUROPattern Microscope and Software. While it states that FDA has determined the device is substantially equivalent to a predicate device, and outlines the indications for use, it does not contain any information about acceptance criteria, device performance results, specific study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and study details based on the provided document. The document focuses on regulatory approval and compliance rather than technical performance data.

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    K Number
    K131791
    Device Name
    IFA 40: HEP-20-10
    Manufacturer
    EUROIMMUN US
    Date Cleared
    2014-02-26

    (253 days)

    Product Code
    DHN
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K070763,K972145
    Why did this record match?
    Device Name :

    IFA 40: HEP-20-10

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

    The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

    Device Description

    The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the EUROIMMUN IFA 40: HEp-20-10 device, based on the provided text:

    Acceptance Criteria and Device Performance

    CriteriaAcceptance Criteria (Implicit/Explicit)Reported Device Performance and Confidence Intervals
    Qualitative Agreement with Predicate DeviceNot explicitly stated as a numerical target in the provided text. However, the study aims to demonstrate substantial equivalence, implying high agreement. The predicate device is ImmunoConcepts® HEp-2000 ANA-Ro IFA.Overall Agreement: 94.5% (95% C.I.: 90.4% - 97.2%)
    Positive Agreement: 92.4% (95% C.I.: 83.2% - 97.5%)
    Negative Agreement: 95.5% (95% C.I.: 90.5% - 98.3%)
    Semi-Quantitative Agreement with Predicate Device (Positive/Negative)Not explicitly stated as a numerical target. The study aims to demonstrate substantial equivalence.Overall Agreement: 100.0% (95% C.I.: 97.7% - 100.0%)
    Positive Agreement: 100.0% (95% C.I.: 96.7% - 100.0%)
    Negative Agreement: 100.0% (95% C.I.: 92.3% - 100.0%)
    Semi-Quantitative Agreement with Predicate Device (Pattern Agreement)Not explicitly stated as a numerical target. Implicitly, high agreement is desired.Overall Pattern Agreement: 91.4%
    (Individual pattern agreements range from 66.7% (Nuclear Membrane) to 100.0% (Homogenous, Centromere, Nuclear Dot))
    Precision/ReproducibilityFluorescence Intensity: The results should not exceed an acceptable deviation of +/- 1 intensity level. Positive samples should not be found negative and vice versa. Observed patterns should not change.
    Endpoint Titer: Endpoint titer should not deviate more than +/- 1 titer level.Intra-Assay, Inter-Assay, Inter-Lot, Inter-Observer, Semi-quantitative Reproducibility: All studies met the criteria; results did not exceed +/- 1 intensity level deviation, positive/negative status remained consistent, and patterns did not change. Semi-quantitative reproducibility also showed endpoint titer did not deviate more than +/- 1 titer level.
    Linearity/Assay Reportable RangeMixed patterns should be distinguishable in every dilution. Samples should show a decrease in fluorescence intensity with increasing dilutions. The pattern of the samples should not change with dilution. Acceptable deviation of fluorescence intensity: ± 1 intensity level.Mixed patterns were distinguishable in every dilution. Samples showed a decrease in fluorescence intensity with dilution. The pattern did not change with dilution. Acceptable deviation of fluorescence intensity (± 1 intensity level) was met.
    Analytical Specificity (Cross-Reactivity)No significant cross-reactivity with ANCA-associated vasculitis, Crohn's disease, ulcerative colitis, celiac disease, Chlamydia pneumoniae, and Epstein-Barr virus samples. CDC reference panel results should be in line with CDC characterization.No significant cross-reactivity observed with the tested clinical samples. Results for the CDC reference panel were in line with CDC characterization (with one exception, CDC sample No. 12, which was negative across all three test systems).
    Analytical Specificity (Interfering Substances)Deviation in fluorescence intensity level should not exceed +/- 1. No significant interference.Hemoglobin (up to 1000 mg/dL), bilirubin (up to 40 mg/dL), triglyceride (up to 2000 mg/dL), HAMA, and RF at indicated concentrations had no effect on assay results. Deviation in fluorescence intensity level did not exceed +/- 1. No significant interference observed.
    Assay Cut-off VerificationPrevalence of ANAs in healthy individuals should be within the range of 3.0% - 15% as per the American College of Rheumatology.A prospective study with 138 samples (routine health screening) found a prevalence of 11.6% (95% C.I.: 6.8% - 18.6%) for ANA positivity at the 1:40 dilution, which falls within the 3.0% - 15% range.
    Expected Values/Reference RangePrevalence of ANAs in healthy individuals should be about 3.0% - 15% as per the American College of Rheumatology. Reference range determined as titer
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