Cleared Traditional

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

K124006 · Illumina, Inc. · Pathology
Nov 2013
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K124006 is an FDA 510(k) clearance for the ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY, a System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection (Class II — Special Controls, product code PFR), submitted by Illumina, Inc. (San Diego, US). The FDA issued a Cleared decision on November 19, 2013, 328 days after receiving the submission on December 26, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number K124006 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date November 19, 2013
Days to Decision 328 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code PFR — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5900
Definition The Cftr Gene Mutation Detection System Is Used To Simultaneously Detect And Identify A Specified Panel Of Mutations And Variants In The Cftr Gene Using Sequencing Methods. It Is Intended For Carrier Screening, As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), And As An Initial Test To Aid In The Diagnosis Of Individuals With Suspected Cf. It Is Not Intended For Stand-alone Diagnostic Purposes, Prenatal Diagnostic, Or Pre-implantation Screening.