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510(k) Data Aggregation

    K Number
    K061257
    Device Name
    DBEST HCG PANEL TEST KIT
    Manufacturer
    AMERITEK USA, INC.
    Date Cleared
    2007-05-04

    (365 days)

    Product Code
    JHI,LCX
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DBEST HCG PANEL TEST KIT

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

    dBest hCG Panel Test Kit is a simple one step immunochromatographic assay for rapid, semi-quantitative detection of hCG in urine with cutoffs of 25, 100, 500, 2,000 and 1.0,000 mlU/mL. The dBest hCG Panel Test Kits are for professional, physician's offices laboratory and OTC use, for the early detection of pregnancy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "dBest hCG Panel Test Kits." It does not contain the detailed information required for a study report on acceptance criteria and device performance. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or study types (MRMC, standalone, etc.) from this document. This document is a regulatory approval, not a scientific study report.

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