LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K034057
    Device Name
    LACRYTEST
    Manufacturer
    ADIATEC SA
    Date Cleared
    2004-03-09

    (70 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K964152
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADIATEC SA

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

    Lacrytest is a rapid immunoassay for the detection of total IgE in tears, Semi-quantitative detection of total IgE In tears ( 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.

    Device Description

    Lacrytest (marked CE) allows the rapid and specific determination of total IgE in tears (in vivo/in vitro). This test is a simple and rapid immuno-chromatographic test, which enables the identification of allergic conjunctivitis in one single step. Its main advantage is that it can be done in vivo without being invasive. The speed and simplicity of this unique test enables a better and faster treatment of the patient. Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear samples is required: Lacrytest uses monoclonal and polyclonal antibodies to detect total IgE in tears. Lacrytest gives results from just one teardrop, and is placed in contact with the patient's eye for less than three minutes, causing minimum discomfort when compared to the Schirmer assay. Doctors do not have to take tear sample, and an indicator appears on the strip when enough tear fluid has been absorbed. The test strip is then soaked with sterile water and the evaluation of amount of total IgE detected. The results appear in the form of easily visible red-violet lines in the presence of total IgE levels greater than 2,5 KUI/L (the detection limit). These results are stable and can be archived. The test can be used in the laboratory, in the doctor's surgery or on a home visit.

    AI/ML Overview

    Here's an analysis of the provided text to extract the requested information about the Lacrytest device:

    Acceptance Criteria and Device Performance

    The acceptance criteria for the Lacrytest device are implicitly established by comparison to the predicate device, UniCAP total IgE FEIA Assay. The document primarily focuses on demonstrating comparable sensitivity and specificity.

    Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance Criteria (Implied by Predicate UniCAP)Reported Device Performance (Lacrytest)
    SensitivityNot explicitly stated but UniCAP is 91.7%91.75% (comparable to UniCAP)
    SpecificityNot explicitly stated but UniCAP is 98.5%98.53% (equal to UniCAP)
    Detection Limit
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1