Cleared Traditional

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

K083294 · Nanosphere, Inc. · Pathology

Jul 2009

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K083294 is an FDA 510(k) clearance for the VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST, a System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II — Special Controls, product code NUA), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on July 24, 2009, 256 days after receiving the submission on November 10, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 866.5900.

Submission Details

510(k) Number	K083294 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2008
Decision Date	July 24, 2009
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Pathology (PA)
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.