Cleared Traditional

K121894 - XTAG GASTROINTESTINAL PATHOGEN PANEL(GP...

K121894 is an FDA 510(k) clearance for XTAG GASTROINTESTINAL PATHOGEN PANEL(GP..., manufactured by Luminex Molecular Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code PCH cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K121894 · Luminex Molecular Diagnostics, Inc. · Microbiology device
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Mar 2013
Decision
265d
Days
Class 2
Risk

K121894 is an FDA 510(k) clearance for the XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP.... 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 Cleared decision on March 21, 2013 after a review of 265 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Luminex Molecular Diagnostics, Inc. devices

FDA 510(k) Submission Details - K121894

510(k) Number K121894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date March 21, 2013
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 102d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

PCH Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01326013 Completed Observational Industry-sponsored

A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel

A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel (xTAG GPP) in Patients With Signs and Symptoms of Infectious Colitis and Gastroenteritis

1534
Patients (actual)
6
Sites
Condition studied Infectious; Colitis; Gastroenteritis
Eligibility All sexes
Principal investigator Jeremy Liu, Ph.D
Sponsor Luminex Molecular Diagnostics (industry)
Started 2011-06-01 → Primary completion 2012-02-01 → Completed 2012-03-01
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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

All 32
Devices cleared under the same product code (PCH) and FDA review panel - the closest regulatory comparables to K121894.
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
K142501 · Cepheid · Nov 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
K140647 · Luminex Molecular Diagnostics, Inc. · Oct 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
K140377 · Luminex Molecular Diagnostics, Inc. · Sep 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
DEN130003 · Luminex Molecular Diagnostics, Inc. · Jan 2013