Cleared Traditional

INPLEX CF MOLECULAR TEST

K063787 · Third Wave Technologies, Inc. · Pathology

Mar 2008

Decision

448d

Days

Class 2

Risk

About This 510(k) Submission

K063787 is an FDA 510(k) clearance for the INPLEX CF MOLECULAR TEST, a System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II — Special Controls, product code NUA), submitted by Third Wave Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on March 13, 2008, 448 days after receiving the submission on December 21, 2006. This device falls under the Pathology review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number	K063787 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2006
Decision Date	March 13, 2008
Days to Decision	448 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.