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510(k) Data Aggregation

    K Number
    K181473
    Device Name
    DENV Detect NS1 ELISA
    Manufacturer
    InBios International, Inc.
    Date Cleared
    2018-08-27

    (84 days)

    Product Code
    QCU
    Regulation Number
    866.3945
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    QCU

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

    The DENV Detect™ NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 - day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision.

    This assay is not FDA cleared or approved for testing blood or plasma donors.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "DENV Detect™ NS1 ELISA", which is for the early detection of Dengue virus NS1 antigen. The document does not include information about acceptance criteria or specific study results to prove the device meets said criteria. It primarily covers the FDA's decision regarding substantial equivalence.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for the test set and data provenance.
    3. Number of experts used and their qualifications for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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