Cleared Traditional

K083294 - VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083294 · Nanosphere, Inc. · Pathology device
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Jul 2009
Decision
256d
Days
Class 2
Risk

K083294 is an FDA 510(k) clearance for the VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (product code NUA), Class II - Special Controls.

Submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on July 24, 2009 after a review of 256 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5900 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanosphere, Inc. devices

Submission Details

510(k) Number K083294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 77d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.