Cleared Traditional

XTAG CF60 KIT V2

K083845 · Luminex Molecular Diagnostics, Inc. · Pathology

Dec 2009

Decision

352d

Days

Class 2

Risk

About This 510(k) Submission

K083845 is an FDA 510(k) clearance for the XTAG CF60 KIT V2, 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 December 11, 2009, 352 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	K083845 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 24, 2008
Decision Date	December 11, 2009
Days to Decision	352 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.