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510(k) Data Aggregation

    K Number
    K231151
    Device Name
    Kenota 1 Total IgE; Kenota 1 (instrument)
    Manufacturer
    Kenota Inc.
    Date Cleared
    2024-05-31

    (403 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Type
    Dual Track
    Panel
    Immunology
    Reference & Predicate Devices
    K161899
    Why did this record match?
    Product Code :

    DGC

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

    The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.

    Device Description

    The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.

    AI/ML Overview

    Here's an analysis of the provided text to extract acceptance criteria and study details for the Kenota 1 Total IgE device:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for semi-quantitative classification are implied by the "Percent in ATE" (Allowable Test Error) within the method comparison study, where ATE means the result is within one category of the comparator. While explicit thresholds for numeric precision are provided, the primary acceptance for classification appears centered around this categorical agreement.

    Performance MetricAcceptance Criteria (Implied/Directly Stated)Reported Device Performance
    Semi-quantitative Agreement (Overall)Not explicitly stated as a percentage, but shown for each range and overall. The study aims to achieve a high "Percent in ATE" (Allowable Test Error).96.4% in ATE (344/357), with a 95% CI of (93.9%; 97.9%)
    Semi-quantitative Agreement (Low Range)Implied high percentage in ATE96.8% in ATE (183/189)
    Semi-quantitative Agreement (Middle Range)Implied high percentage in ATE96.6% in ATE (84/87)
    Semi-quantitative Agreement (High Range)Implied high percentage in ATE95.1% in ATE (77/81)
    Erroneous Results (LER)Implied low percentage, ideally 0%0.0% in LER (0/357), with a 95% CI of (0.0%; 1.1%)
    Within-laboratory Precision (Cartridge lots) - %CVNot explicitly stated, but generally, lower %CV indicates better precision.Low: 19.6%; Medium: 14.5%; High: 15.9%; Very High: 9.7%
    Within-laboratory Precision (Instruments) - %CVNot explicitly stated, but generally, lower %CV indicates better precision.Low: 13.6%; Medium: 14.0%; High: 15.3%; Very High: 6.8%
    Fingerstick Repeatability - %CVNot explicitly stated, but generally, lower %CV indicates better repeatability.5-34 kU/L: 10.6%; 35-100 kU/L: 8.7%; 101-200 kU/L: 9.8%; 201-540 kU/L: 8.4%; 541-900 kU/L: 7.2%; Entire Range: 8.3%
    Multi-site Reproducibility (Controls) - %CVNot explicitly stated, but generally, lower %CV indicates better reproducibility.Low Control: 12.2%; High Control: 11.6%
    Linearity (Categorical Agreement)100% agreement expected where possible, with some allowance for boundary cases (e.g., 900 range, 53.3% for ±2 degrees tilt.
    Lighting (Bias)
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