LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983190
    Device Name
    DBEST OPIATES TEST KIT
    Manufacturer
    AMERITEK, INC.
    Date Cleared
    1998-11-18

    (68 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DBEST OPIATES TEST KIT

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

    dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml. The dBest Opiates Test Kits are for professional and laboratory use only.

    Device Description

    dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a diagnostic device, the dBest Opiates Test Kit. It does not contain the detailed acceptance criteria or a study write-up proving the device meets those criteria.

    Therefore, I cannot provide the requested information from this document. The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not elaborate on the performance data or studies that led to this determination.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1