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510(k) Data Aggregation

    K Number
    K030628
    Device Name
    SAS RSV CONTROL KIT
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2003-03-17

    (18 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SAS RSV CONTROL KIT

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

    SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.

    The test is for professional use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "SASTM RSV Control Kit."

    This letter primarily focuses on:

    • Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
    • Regulatory Classification: Identifying the device as Class I and its regulation number and product code.
    • General Controls: Reminding the applicant of general control provisions of the Act (registration, listing, GMP, labeling, etc.).
    • Indications for Use: Confirming the intended use of the SASTM RSV Control Kit as controls for use with the SASTM RSV Test Kit.

    The document does not include any performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications that would be required to describe acceptance criteria and a study proving device performance against them.

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