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510(k) Data Aggregation

    K Number
    K141341
    Device Name
    CL DETECT RAPID TEST
    Manufacturer
    INBIOS INTERNATIONAL INC.
    Date Cleared
    2014-11-14

    (177 days)

    Product Code
    PIT
    Regulation Number
    866.3870
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    PIT

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

    The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "CL Detect™ Rapid Test" and its Indications for Use statement. It declares the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only states the intended use of the device:

    Device Name: CL Detect™ Rapid Test

    Indications for Use: The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four-month-old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL Detect™ Rapid Test is to aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

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