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    K Number
    K091283
    Device Name
    CAPILLARYS NEONAT HB (PN 2006)
    Manufacturer
    SEBIA
    Date Cleared
    2010-02-22

    (297 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K031897,K072879,K083592
    Why did this record match?
    Device Name :

    CAPILLARYS NEONAT HB (PN 2006)

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

    The CAPILLARYS NEONAT Hb kit is designed for the separation of the normal hemoglobins (F and A) in blood samples from human new-borns, and for the major hemoglobin vanants (S, C, E, D and Bart's), by electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 System. The CAPILLARYS NEONAT Hb kit is designed for laboratory use.

    The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.

    For In Vitro Diagnostic Use.

    The Hb AF Control is designed:

    • for the migration control before starting a new analysis sequence and for the qualitative quality control, for human hemoglobins A and F with the SEBIA CAPILLARYS NEONAT Hb electrophoresis procedure used with the CAPILLARYS 2 system, and,

    • for the quantitative quality control for detection of the human hemoglobins A, F and A2 with the SEBIA electrophoresis procedures : HYDRAGEL HEMOGLOBIN(E) used with the HYDRASYS system, CAPILLARYS HEMOGLOBIN(E) used with the CAPILLARYS system and MINICAP HEMOGLOBIN(E) used with the MINICAP system.

    The Hb AF Control is designed for laboratory use. It should be used (with its bar code label for the CAPILLARYS and MINICAP procedures) like a normal human blood. The values obtained must fall within the range provided with each batch of Hb AF Control.

    For In Vitro Diagnostic Use.

    Device Description

    The CAPILLARYS 2 is an automated analyzer which performs a complete hemoglobin profile for the qualitative analysis of hemoglobins. The assay is performed on the hemolysate of whole blood samples previously collected on filter paper.

    AI/ML Overview

    The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically the CAPILLARYS NEONAT Hb kit and Hb AF CONTROL. This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical study results with specific acceptance criteria, sample sizes for training or test sets, or ground truth establishment methods for an AI/algorithm-based device.

    Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, and AI-specific metrics (MRMC, standalone performance, training set ground truth) is not present in the provided document.

    This document confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, without delving into the detailed experimental design and results that would be expected for a novel AI-driven diagnostic.

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