Cleared Special

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

K191160 · Luminex Molecular Diagnostics, Inc. · Microbiology

Nov 2019

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

K191160 is an FDA 510(k) clearance for the xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP), a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on November 4, 2019, 187 days after receiving the submission on May 1, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K191160 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2019
Decision Date	November 04, 2019
Days to Decision	187 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class	Class II — 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.