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    K Number
    DEN130011
    Device Name
    ILLUMINA MISEQDX PLATFORM
    Manufacturer
    ILLUMINA, INC.
    Date Cleared
    2013-11-19

    (57 days)

    Product Code
    PFF
    Regulation Number
    862.2265
    Type
    Post-NSE
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k133136
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    Device Name :

    ILLUMINA MISEQDX PLATFORM

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

    The MiSeqDx Platform is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples. The MiSeqDx Platform is not intended for whole genome or de novo sequencing.

    Device Description

    The MiSeqDx Platform is a high throughput DNA sequence analyzer for clinical use.

    The MiSeqDx Platform consists of the MiSeqDx instrument and data analysis software. It is for use with the MiSeqDx Universal Kit 1.0 [MiSeqDx reagent cartridge, MiSeqDx flow cell, SBS Solution (PR2 buffer)] for library preparation and sample indexing (K133136). The end-user inputs extracted genomic DNA to be sequenced and provides the Analyte Specific Reagents (ASRs) to develop a sequencing assay that targets their sequence of interest.

    AI/ML Overview

    The Illumina MiSeqDx Platform is a high-throughput DNA sequencing instrument. The acceptance criteria and supporting studies are detailed below:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the MiSeqDx Platform are primarily derived from the special controls stipulated in 21 CFR 862.2265, focusing on accuracy and reproducibility across various genomic features.

    Acceptance Criteria (from 21 CFR 862.2265 (B) items ii, iii, vii, viii)Reported Device Performance (from Accuracy and Reproducibility Studies)
    Accuracy:
    - Ability to detect single nucleotide variants (SNVs).Study 1: All SNVs had 100% agreement with the reference sequence. PPA ranged from 89.5% to 95.8% (due to missed indels, not SNVs). NPA was 100%.
    Study 2: PPA for SNVs and Indels was 94.1%, NPA was 100%.
    - Ability to detect insertions and deletions (indels).Study 1: Variants missed were 1-base insertions or 1-base deletions in homopolymer regions (e.g., Amplicon 9 and 95).
    Study 3 (CFTR Assay): 1-base insertion, 3-base deletion, and 2-base deletion were detected with 100% correct calls.
    Overall: Validated for detection of SNVs and up to 3-base deletions. Evaluation of 1-base insertions was limited to 3 different insertions on 3 separate chromosomes. The system has problems detecting 1-base insertions or deletions in homopolymer tracts. 2 out of 3 1-base insertions tested were called correctly (those in non-homopolymer regions). 3 out of 4 1-base deletions called correctly (those in non-homopolymer regions).
    - Performance across varying sequence context (e.g., GC-rich regions, homopolymer runs, different chromosomes).Study 1 & 3 summary:
    • GC content > 19% and
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