Cleared Traditional

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267

K083846 · Luminex Molecular Diagnostics, Inc. · Pathology

Sep 2009

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K083846 is an FDA 510(k) clearance for the XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267, a System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II — Special Controls, product code NUA), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on September 1, 2009, 251 days after receiving the submission on December 24, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number	K083846 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 24, 2008
Decision Date	September 01, 2009
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

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.