Cleared Traditional

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

K132750 · Illumina, Inc. · Pathology
Nov 2013
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K132750 is an FDA 510(k) clearance for the ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY, a System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection (Class II — Special Controls, product code PFS), submitted by Illumina, Inc. (San Diego, US). The FDA issued a Cleared decision on November 19, 2013, 77 days after receiving the submission on September 3, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number K132750 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2013
Decision Date November 19, 2013
Days to Decision 77 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code PFS — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5900
Definition The Cftr Gene Variant Detection System Is Used To Sequence Specified Regions Of The Cftr Gene To Detect Gene Variants. It Is Intended As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), Those With Atypical Or Non-classic Presentation Of Cf, Or When Other Mutation Panels Have Failed To Identify Both Causative Mutations. It Is Not Intended For Screening (carrier, Newborn, Population, Or Pre-implantation), Prenatal Diagnostic, Or Used For Stand-alone Diagnostic Purposes