# K251721: Xpert GI Panel

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Jan 16, 2026 after 226 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: 2 generations back to DEN130003 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140407: Filmarray Gastrointestinal (GI) Panel, Biofire Diagnostics (2014) Summary page 8.

## Indications for use
The Xpert GI Panel, performed on the GeneXpert® Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel: Pathogens Detected: Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium Virus: Norovirus GI/GII Pathogens Reported: Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae Parasites: Giardia, Cryptosporidium Virus: Norovirus Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co- infection with pathogens not included in the Xpert GI Panel. The pathogen 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.

Source page: https://510kreport.com/device/K251721
Methodology: https://510kreport.com/methodology