Not Cleared Post-NSE

DEN050004 - TAG-IT CYSTIC FIBROSIS KIT

DEN050004 is an FDA 510(k) submission for TAG-IT CYSTIC FIBROSIS KIT, manufactured by Tm Bioscience Corporation. The device is a Class 2 Pathology device with product code NUA cleared through the Post-NSE 510(k) pathway after a 34-day FDA review.

DEN050004 · Tm Bioscience Corporation · Pathology device
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May 2005
Decision
34d
Days
Class 2
Risk

DEN050004 is an FDA 510(k) submission (not cleared) 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 Not Cleared (DENG) decision on May 9, 2005 after a review of 34 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

FDA 510(k) Submission Details - DEN050004

510(k) Number DEN050004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 05, 2005
Decision Date May 09, 2005
Days to Decision 34 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 78d · This submission: 34d
Pathway characteristics

NUA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

All 11
Devices cleared under the same product code (NUA) and FDA review panel - the closest regulatory comparables to DEN050004.
TAG-IT CYSTIC FIBROSIS KIT
K060627 · Tm Bioscience Corporation · Jun 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
K060543 · Clinical Micro Sensors, Inc. · Mar 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
K051435 · Clinical Micro Sensors · Jan 2006
DEN050004 · TAG-IT CYSTIC FIBROSIS KIT
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