# K121894: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas GPP) Luminex Magpix

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Mar 21, 2013 after 265 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K142501: Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (2014), 1 descendant of its own
- K140083: Verigene Enteric Pathogen Nucleic Acid Test ( EP) (2014), 1 descendant of its own
- K171511: RIDA GENE Norovirus GI/GII (2017), 0 descendants of its own
- K163571: Great Basin Stool Bacterial Pathogens Panel (2017), 0 descendants of its own
- K140647: Xtag Gastrointestinal Pathogen Panel (GPP)/Xtag Data Analysis Software for GPP (Tdas GPP) (2014), 0 descendants of its own

## 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, parasitic, and bacterial nucleic acids in human stool specimens 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: * Campylobacter (C jejunt, C colt and C. tart only) * Clostridtum difficile (C. dffficile) toxin A/B * Ctypiosporidium (C. parvum and C. homtnts only) * Eschertchiacolt (E. colt) 0 15 7 * Enterotoxigenic Escherichta colt (ETEC) LT/ST * Giardia (G. lamblta only also known as G. tntesttnalisand G. duodenalts) * Norovirus GI/GII * Rotavirus A * Salmonella * Shiga-like Toxin producing E. colt (STEC) stx l/stx 2 * Shigella (S. boydti, S. sonnet, S.flexneri and S. dysentertae) 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®O 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® MAGPIX® instrument.

Source page: https://510kreport.com/device/K121894
Methodology: https://510kreport.com/methodology