Not Cleared Post-NSE

DEN130003 - XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN130003 · Luminex Molecular Diagnostics, Inc. · Microbiology device
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Jan 2013
Decision
3d
Days
Class 2
Risk

DEN130003 is an FDA 510(k) submission (not cleared) for the XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GP.... Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on January 14, 2013 after a review of 3 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - the FDA microbiology 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 Microbiology review framework.

View all Luminex Molecular Diagnostics, Inc. devices

Submission Details

510(k) Number DEN130003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 11, 2013
Decision Date January 14, 2013
Days to Decision 3 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 102d · This submission: 3d
Pathway characteristics

Device Classification

Product Code PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3990
Definition A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.
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 Microbiology devices follow this clearance model.

Regulatory Peers - PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

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