Xtag Gastrointestinal Pathogen Panel(gpp)/Xtag Data Analysis Software For Gpp(t…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140647 FDA 510(k)
- FDA Product Code
- PCH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3990 FDA 510(k)
- Regulation Number
- 866.3990 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. It is a highly scalable gastrointestinal test with customizable detection of bacterial, viral, and parasitic pathogens to rule out the causes of infectious diarrhea.
The device is supplied as a system comprising the XTAG GPP assay and XTAG Data Analysis Software for GPP (TDAS GPP). It is used in clinical laboratory settings for the analysis of human stool specimens. The device received FDA 510(k) clearance (K140647) on October 24, 2014, and is classified as a Class II medical device under regulation number 866.3990 with product code PCH. It is intended for use in microbiology specialty applications.
Frequently asked questions
What is the XTAG Gastrointestinal Pathogen Panel (GPP) used for?
The XTAG GPP is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. It helps rule out the causes of infectious diarrhea by detecting a range of pathogens in a single test.
What components are included in the XTAG GPP system?
The XTAG GPP system comprises the XTAG GPP assay and the XTAG Data Analysis Software for GPP (TDAS GPP). Together, these components enable the detection of pathogens in stool specimens and the analysis of test results in a clinical laboratory setting.
Is the XTAG GPP system intended for use in point-of-care or clinical laboratory settings?
The XTAG GPP system is intended for use in clinical laboratory settings for the analysis of human stool specimens. It is not designed for point-of-care use and requires laboratory instrumentation and trained personnel to perform the test and interpret results using the TDAS GPP software.
What type of specimens does the XTAG GPP test analyze?
The XTAG GPP test analyzes human stool specimens from individuals presenting with signs and symptoms of infectious colitis or gastroenteritis. It is designed to detect nucleic acids from various viral, bacterial, and parasitic pathogens associated with infectious diarrhea.
How is the XTAG GPP system supplied to users?
The XTAG GPP system is supplied as a combined system that includes both the XTAG GPP assay reagents and the XTAG Data Analysis Software for GPP (TDAS GPP). This integrated system supports the full workflow from specimen processing to result interpretation in the clinical laboratory.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: xTAG® GPP | Gastrointestinal Pathogen Panel | Diasorin, PDF xTAG Gastrointestinal Pathogen Panel (GPP) - DiaSorin, PDF REVIEW MEMORANDUM - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140647 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Molecular Diagnostics, Inc.
Sources (1)
- FDA 510(k) K140647 24 fields · synced Sep 22, 2026