Cleared Special

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

K163336 · Luminex Molecular Diagnostics, Inc. · Medical Genetics

Dec 2016

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K163336 is an FDA 510(k) clearance for the xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR, a System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II — Special Controls, product code NUA), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 15, 2016, 17 days after receiving the submission on November 28, 2016. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number	K163336 FDA.gov
FDA Decision	Cleared SESK
Date Received	November 28, 2016
Decision Date	December 15, 2016
Days to Decision	17 days
Submission Type	Special
Review Panel	Medical Genetics (MG)
Summary	Statement

Device Classification

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