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510(k) Data Aggregation

    K Number
    K990842
    Device Name
    SAS ROTA TEST
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1999-08-09

    (147 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SAS ROTA TEST

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

    The SASTM Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by rotavirus infection. This test is for professional use only.

    Device Description

    rapid, membrane-based immunogold assay

    AI/ML Overview

    This is a K990842, clearance letter for SAS™ Rota Test from the FDA. This document does not contain the detailed study information regarding acceptance criteria and device performance. It primarily serves as a notification of the FDA's decision regarding substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications based on the provided text.

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