# K242877: BioCode Gastrointestinal Pathogen Panel (GPP)

- Pathway: 510(k) (Traditional)
- Applicant: Applied BioCode, Inc.
- Decided: Jan 10, 2025 after 109 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: 3 generations back to DEN130003 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190585: Biocode Gastrointestinal Pathogen Panel (GPP), Applied BioCode, Inc. (2019) Summary page 6.

## Indications for use
The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved stool samples or stool preserved in Cary-Blair transport medium obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria, parasites, and viruses are identified using the BioCode Gastrointestinal Pathogen Panel: ▪ Campylobacter (C. jejuni/C. coli) ▪ Clostridium difficile (C. difficile) toxin A/B (Fresh samples only) ▪ Salmonella spp ▪ Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio parahaemolyticus ▪ Yersinia enterocolitica ▪ Enteroaggregative Escherichia coli (EAEC) ▪ Enterotoxigenic Escherichia coli (ETEC) lt/st ▪ E. coli O157 serogroup ▪ Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 ▪ Shigella/ Enteroinvasive Escherichia coli (EIEC) ▪ Cryptosporidium spp (C. parvum/C. hominis) ▪ Entamoeba histolytica ▪ Giardia lamblia (also known as G. intestinalis and G. duodenalis) ▪ Adenovirus F 40/41 ▪ Norovirus GI/GII ▪ Rotavirus A The BioCode 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. For In Vitro Diagnostic Use Only. For Prescription Use Only. Positive results do not rule out co-infection with organisms not included in the BioCode GPP. The agent detected may not be the definite cause of the disease. 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 Adenovirus 40/41, Campylobacter, E. coli O157, Shigella/EIEC, Yersinia enterocolitica, and Giardia lamblia were established additionally with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, Giardia lamblia, Yersinia enterocolitica and Vibrio (V. parahaemolyticus, V. vulnificus, and V. cholerae) were established primarily using contrived clinical specimens.

Source page: https://510kreport.com/device/K242877
Methodology: https://510kreport.com/methodology