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    K Number
    K161527
    Device Name
    Teco Creatinine Enzymatic Reagent Kit
    Manufacturer
    TECO DIAGNOSTICS, INC.
    Date Cleared
    2017-07-21

    (414 days)

    Product Code
    JFY
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K050283
    Why did this record match?
    Device Name :

    Teco Creatinine Enzymatic Reagent Kit

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

    Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).

    Device Description

    Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.

    AI/ML Overview

    The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.

    Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.

    Here's the breakdown of the information that is applicable from your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.

    Performance CharacteristicAcceptance Criteria (Implied)Reported Device Performance (Teco Creatinine Enzymatic Reagent Kit)
    Intended UseQuantitative determination of creatinine in human serumQuantitative determination of creatinine in human serum
    SpecimenSerumSerum
    MethodologyEnzymaticEnzymatic
    Linearity (Measuring Range)Comparable to predicate (0.04 to 5.1 mg/dL for serum)0.37 - 5.06 mg/dL
    Correlation (R²)High correlation with predicate (R closer to 1.0)R² = 0.9986 (compared to predicate)
    Storage2-8 °C2-8 °C
    Intra-assay RepeatabilityLow CV% (e.g.,
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