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510(k) Data Aggregation

    K Number
    K201089
    Device Name
    ARK Lacosamide Assay
    Manufacturer
    ARK Diagnostics, Inc.
    Date Cleared
    2021-08-05

    (469 days)

    Product Code
    NWM
    Regulation Number
    862.3350
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K083799
    Why did this record match?
    Device Name :

    ARK Lacosamide Assay

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

    The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.

    Device Description

    The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between drug in the specimen and lacosamide labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.

    The ARK Lacosamide Assay consists of reagents R1 anti-lacosamide polyclonal antibody with substrate and R2 lacosamide labeled with bacterial G6PDH enzyme.

    AI/ML Overview

    The provided text describes the ARK Lacosamide Assay, a homogeneous enzyme immunoassay for quantitative determination of lacosamide in human serum. This device is intended for monitoring lacosamide levels to ensure appropriate therapy. The substantial equivalence is demonstrated through comparative testing against a predicate device (ARKTM Topiramate Assay, K083799) and various performance characteristic studies.

    Here's a breakdown of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Limit of Quantitation (LoQ)Acceptable inter-assay precision (1.00 µg/mL) or ≤0.20 µg/mL (for ≤1.00 µg/mL) between 1st and 2nd order regressed values.Linear relationship demonstrated between 0.40 and 25.00 µg/mL (y = 0.9998x - 0.0170). Differences within acceptable limits.
    Precision (Total CV)≤10% total CVFor controls and human serum samples, total CVs ranged from 3.9% to 4.5%.
    Interfering SubstancesMeasurement of lacosamide resulted in ≤10% errorAll tested interfering substances resulted in ≤10% error (recoveries ranging from 95.8% to 103.5%).
    Specificity (O-Desmethyl Metabolite)Not clinically significant (
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