# K180041: BioCode Gastrointestinal Pathogen Panel (GPP)

- Pathway: 510(k) (Traditional)
- Applicant: Applied BioCode, Inc.
- Decided: Sep 28, 2018 after 266 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
Longest line of descent: 1 generation back to DEN130003 (2013). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K190585: Biocode Gastrointestinal Pathogen Panel (GPP) (2019), 1 descendant of its own
- K242877: BioCode Gastrointestinal Pathogen Panel (GPP) (2025), 0 descendants of its own

## Indications for use
The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative, gastrointestinal microorganism multiplexed nucleic acid-based assay capable of detecting of nucleic acids from the following organisms in unpreserved stool and Cary-Blair media: • Adenovirus 40/41 • Campylobacter (C. jejuni, C. coli) • Clostridium difficile (C. difficile) toxin A/B (from fresh specimens only) • Cryptosporidium (C. parvum, C. hominis) • Entamoeba histolytica • Escherichia coli (E. coli) O157 • Enterotoxigenic E. coli (ETEC) LT/ST • Enteroaggregative E. coli (EAEC) • Giardia lamblia (also known as G. intestinalis and G. duodenalis) • Norovirus GI/GII • Rotavirus A • Salmonella spp. • Shiga-like Toxin producing E. coli (STEC) stx1/stx2 • Shigella (S. boydii, S. sonnei, S. flexneri, S. dysenteriae)/EIEC • Vibrio spp. (V. cholerae, V. parahaemolyticus, V. vulnificus), specific identification of V. parahaemolyticus • Yersinia enterocolitica The BioCode Gastrointestinal Pathogen Panel (GPP) is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the BioCode Gastrointestinal Pathogen Panel (GPP). The agent detected may not be the cause of patient illness. Negative 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. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Campylobacter spp., E. coli O157, Shigella/EIEC, Yersinia enterocolitica, and Adenovirus 40/41 were established primarily with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, and Vibrio spp. (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) were established primarily using contrived clinical specimens.

Source page: https://510kreport.com/device/K180041
Methodology: https://510kreport.com/methodology