Xtag Gastrointestinal Pathogen Panel(Gpp)/Xtag Data Analysis Software for Gpp(Tdas GPP)
FDA 510(k) K140647 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- Xtag Gastrointestinal Pathogen Panel(Gpp)/Xtag Data Analysis Software for Gpp(Tdas GPP)
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, Ontario, CA - Received
- March 13, 2014
- Decision date
- October 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- Microbiology
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…
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| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
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Questions and answers
When was Xtag Gastrointestinal Pathogen Panel(Gpp)/Xtag Data Analysis Software for Gpp(Tdas GPP) cleared by the FDA?
Xtag Gastrointestinal Pathogen Panel(Gpp)/Xtag Data Analysis Software for Gpp(Tdas GPP) (K140647) received a 510(k) decision of Substantially Equivalent on October 24, 2014, 225 days after the submission was received.
What is the product code of K140647?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.