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    K Number
    K112491
    Device Name
    SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
    Manufacturer
    SEBIA
    Date Cleared
    2012-05-24

    (269 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

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

    The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 instrument. The CAPILLARYS HEMOGLOBIN(E) kit is designed for laboratory use.

    The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.

    For In Vitro Diagnostic Use.

    Device Description

    The CAPILLARYS 2 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of packed red blood cells from blood samples collected in tubes containing KoEDTA or KsEDTA as anticoagulant.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Sebia CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 instrument." However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.

    The document mainly focuses on:

    • The FDA's decision of substantial equivalence.
    • The regulatory classification (Class II, Product Code GKA).
    • General information about FDA regulations for medical devices.
    • The intended use of the device.

    Therefore, I cannot provide the specific details about acceptance criteria, performance, sample sizes, ground truth establishment, or expert qualifications as these are not present in the given text.

    To answer your request, I would need a different document, typically a Summary of Safety and Effectiveness or a full clinical study report, which is usually part of the 510(k) submission but not contained within this FDA correspondence letter.

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