Cleared Special

K163347 - xTAG Cystic Fibrosis 39 Kit v2 (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163347 · Luminex Molecular Diagnostics, Inc. · Medical Genetics device
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Dec 2016
Decision
17d
Days
Class 2
Risk

K163347 is an FDA 510(k) clearance for the xTAG Cystic Fibrosis 39 Kit v2. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (product code NUA), Class II - Special Controls.

Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 15, 2016 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5900 - the FDA medical genetics device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Luminex Molecular Diagnostics, Inc. devices

Submission Details

510(k) Number K163347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 28, 2016
Decision Date December 15, 2016
Days to Decision 17 days
Submission Type Special
Review Panel Medical Genetics (MG)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
382d faster than avg
Panel avg: 399d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 Medical Genetics devices follow this clearance model.