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510(k) Data Aggregation

    K Number
    K031604
    Device Name
    GLYCOMARK
    Manufacturer
    TOMEN AMERICA INC.
    Date Cleared
    2003-09-22

    (123 days)

    Product Code
    NOZ,JIS,JJX
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K934070
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOMEN AMERICA INC.

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

    The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.

    Device Description

    The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.

    AI/ML Overview

    The provided text describes the 510(k) summary for the GlycoMark™ device. It includes nonclinical and clinical data, but it does not specify acceptance criteria for the device's performance in a traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, it presents performance characteristics and clinical study results primarily for comparison with a predicate device and to demonstrate safety and effectiveness for its intended use.

    However, I can extract the reported device performance and infer "acceptance" by its successful 510(k) clearance by the FDA, implying these performance characteristics were deemed adequate.

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Since explicit "acceptance criteria" are not stated as quantitative targets that the device must meet (e.g., "sensitivity must be >X%"), I will present the reported performance characteristics. The FDA's clearance (K031604) implies these performance results were acceptable for market entry.

    CharacteristicInferred Acceptance Criteria (Meeting predicate similarities & clinical relevance)Reported Device Performance (GlycoMark™)
    Analytical SensitivityShould be sufficient to detect clinically relevant levels of 15AG.0.2 µg/mL (defined as mean 15AG concentration plus one standard deviation of a saline blank).
    Within-Assay PrecisionComparable to predicate or clinically acceptable for monitoring. (Predicate: Intra-run %CVs less than 2%)Between 1.28 %CV and 3.83 %CV at two levels (low 4.6 µg/mL, high 14.7 µg/mL).
    Between-Assay PrecisionComparable to predicate or clinically acceptable for monitoring. (Predicate: Between-day %CVs between 3% and 4%)Between 0.79 %CV and 3.71 %CV with two control samples and two serum pool samples (concentrations 4.7 µg/mL to 27.0 µg/mL).
    LinearityShould be linear across the expected physiological range of 15AG.Linear up to at least 110 µg/mL 15AG.
    Sample StabilitySamples should be stable under appropriate storage conditions for practical laboratory use.Serum samples stable at room temperature or 2-8°C for up to seven days; endures up to three freeze/thaw cycles.
    Interfering SubstancesShould not be significantly affected by common interfering substances encountered in blood samples.Not affected by hemoglobin up to 125 mg/dL, triglycerides up to 1153 mg/dL, and bilirubin up to 53.3 mg/dL.
    Clinical PerformanceShould demonstrate responsiveness to changes in glycemic control, similarly to or with advantages over existing markers, for intermediate-term monitoring.Demonstrated significant changes vs. baseline (p
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