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510(k) Data Aggregation

    K Number
    K160517
    Device Name
    ARIES System
    Manufacturer
    LUMINEX CORPORATION
    Date Cleared
    2016-04-12

    (48 days)

    Product Code
    OOI,00I
    Regulation Number
    862.2570
    Type
    Special
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARIES System

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

    The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or details about the training set for the ARIES® System. The document is an FDA 510(k) clearance letter and an Indications for Use statement, which primarily confirm regulatory approval and describe the system's intended function.

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    K Number
    K151917
    Device Name
    ARIES System
    Manufacturer
    LUMINEX CORPORATION
    Date Cleared
    2015-10-06

    (85 days)

    Product Code
    OOI,001
    Regulation Number
    862.2570
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARIES System

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

    The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.

    Device Description

    Not Found

    AI/ML Overview

    This document, K151917, is a 510(k) premarket notification for the Luminex ARIES® System, an in vitro diagnostic (IVD) platform. However, the provided text does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.

    The document primarily focuses on:

    • The FDA's determination of substantial equivalence for the device.
    • Regulatory information and responsibilities for the manufacturer.
    • The Indications for Use statement for the ARIES® System.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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