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510(k) Data Aggregation

    K Number
    K954214
    Device Name
    CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
    Manufacturer
    VYSIS
    Date Cleared
    1997-01-21

    (502 days)

    Product Code
    OXP,KIR
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    OXP

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

    This assay is designed to provide a reliable method for the simultaneous detection and enumeration of X and Y chromosomes in interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).

    Device Description

    The CEP X/Y probe is a combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes for the centromeric region of chromosome X and the satellite III DNA at the Yq12 region of chromosome Y.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Hybridization Efficiency:
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