510(k) · Cleared
ClearedXpert GI Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jan 16, 2026 as substantially equivalent to K140407 (Biofire Diagnostics, 2014) after a 226-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Jan 16, 2026
- Review
- 226 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130003 (2013). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCH device
- #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140407 | Filmarray Gastrointestinal (GI) PanelSummary page 8…) Classification Advisory Panel: Microbiology Prescription Use: Yes Predicate Device Assay: FilmArray Gastrointestinal (GI) Panel (K140407) 510(k) Summary Page 3 of 34 Xpert® GI P… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 7 other devices also cite its predicate K140407.
How does its category compare?
All PCH devicesPCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PCH
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCH
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCH
5in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCH
40in 2025
MAUDE reports naming product code PCH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | — | 0 | 0 |
| 2014 | 6 | 120 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 105 | 0 | 0 |
| 2019 | 4 | 191 | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 2 | — | 0 | 47 |
| 2023 | 1 | — | 1 | 62 |
| 2024 | 3 | 271 | 0 | 45 |
| 2025 | 7 | 89 | 5 | 40 |
| 2026 | 3 | 176 | 0 | — |
What is it indicated for?
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…
Read the full statement (245 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251721: Xpert GI Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251721
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026