# K140377: Xtag Gastrointestinal Pathogen Panel (GPP)/Xtag Data Analysis Software for GPP (Tdas GPP)

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Sep 16, 2014 after 214 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130003 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas), Luminex Molecular Diagnostics, Inc. (2013). Our reading of the summary gave K121454, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130003, Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data… (Luminex Molecular Diagnostics, Inc.), granted Jan 14, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Recalls of this device
- Feb 22, 2019 · Class II · Z-1767-2019: Reports have been received of lower MS2 MFI values when using the panel.

## Indications for use
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG GPP: Viruses • Adenovirus 40/41 • Norovirus GI/GII • Rotavirus A Bacteria • Campylobacter (C. jejuni, C. coli and C. lari only) • Clostridium difficile (C. difficile) toxin A/B • Escherichia coli (E. coli) O157 • Enterotoxigenic Escherichia coli (ETEC) LT/ST • Salmonella • Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 • Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) • Vibrio cholerae (V. cholerae) cholera toxin gene (ctx) Parasites • Cryptosporidium (C. parvum and C. hominis only) • Entamoeba histolytica (E. histolytica) • Giardia (G. lamblia only - also known as G. intestinalis and G. duodenalis) The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG Gastrointestinal Pathogen Panel results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. xTAG GPP is not intended to monitor or guide treatment for C. difficile infections. The xTAG GPP is indicated for use with the Luminex® 100/200TM instrument system with xPONENT® software.

Source page: https://510kreport.com/device/K140377
Methodology: https://510kreport.com/methodology