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510(k) Data Aggregation

    K Number
    K974613
    Device Name
    VIROTROL III
    Manufacturer
    BLACKHAWK BIOSYSTEMS, INC.
    Date Cleared
    1998-01-27

    (47 days)

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

    VIROTROL III

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

    VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.

    Device Description

    liquid unassayed human serum based quality control material

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Virotrol III". It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, or MRMC results) from the provided text.

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