510(k) DEN130003
DEN130003 is an FDA 510(k) premarket notification submitted by Luminex Molecular Diagnostics, Inc. for the device "XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)". The FDA issued a decision of De Novo Granted on January 14, 2013. The device falls under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System), a Class II device regulated under 21 CFR 866.3990. Luminex Molecular Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 14, 2013
- Date Received
- January 11, 2013
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
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.