Cleared Special

K060627 - TAG-IT CYSTIC FIBROSIS KIT (FDA 510(k) Clearance)

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

K060627 · Tm Bioscience Corporation · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
90d
Days
Class 2
Risk

K060627 is an FDA 510(k) clearance for the TAG-IT CYSTIC FIBROSIS KIT. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (product code NUA), Class II - Special Controls.

Submitted by Tm Bioscience Corporation (Toronto, Ontario, CA). The FDA issued a Cleared decision on June 7, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5900 - the FDA pathology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tm Bioscience Corporation devices

Submission Details

510(k) Number K060627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2006
Decision Date June 07, 2006
Days to Decision 90 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 77d · This submission: 90d
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 Pathology devices follow this clearance model.