Not Cleared Direct

DEN130042 - MISEQDX UNIVERSAL KIT 1.0

DEN130042 is an FDA 510(k) submission for MISEQDX UNIVERSAL KIT 1.0, manufactured by Illumina, Inc.. The device is a Class 1 Chemistry device with product code PFT cleared through the Direct 510(k) pathway after a 46-day FDA review.

DEN130042 · Illumina, Inc. · Chemistry device
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Nov 2013
Decision
46d
Days
Class 1
Risk

DEN130042 is an FDA 510(k) submission (not cleared) for the MISEQDX UNIVERSAL KIT 1.0. Classified as Reagents For Molecular Diagnostic Test Systems (product code PFT), Class I - General Controls.

Submitted by Illumina, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on November 19, 2013 after a review of 46 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3800 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework.

FDA 510(k) Submission Details - DEN130042

510(k) Number DEN130042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 04, 2013
Decision Date November 19, 2013
Days to Decision 46 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics

PFT Device Classification - Class 1, General Controls

Product Code PFT Reagents For Molecular Diagnostic Test Systems
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3800
Definition A Kit That Is A Set Of Reagents And Consumables Used In The Processing Of Human Genomic Dna Samples Derived From Peripheral Whole Blood, And In The Subsequent Targeted Re-sequencing Of The Resulting Sample Libraries. User-supplied Analyte Specific Reagents Are Required For The Preparation Of Libraries Targeting Specific Genomic Regions Of Interest. The Kit Is Intended For Use As Part Of Molecular Diagnostic Test Systems.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

DEN130042 · MISEQDX UNIVERSAL KIT 1.0
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