DEN130003 is an FDA 510(k) submission for the XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS). This device is classified as 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 Not Cleared (DENG) decision on January 14, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3990. 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..
| 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 | — |
| 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. |