510(k) · Cleared
ClearedGreat Basin Stool Bacterial Pathogens Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Basin Scientific, Inc. · PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jul 12, 2017 as substantially equivalent to K140083 (Nanosphere, Inc., 2014) after a 205-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Jul 12, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- PCI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K121894 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK121894 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 1 generation backK140083 Verigene Enteric Pathogen Nucleic Acid Test ( EP)Nanosphere, Inc. · 2014 · Recalled
- This deviceK163571 Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K121894 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −1 | K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( EP) | Nanosphere, Inc. | 2014 | 5 |
| 0 (this device) | K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | 2017 | — |
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 PCI? 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 PCI device
- #1 K250358 BD Enteric Bacterial Panel for BD COR System…score 11.8 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( EP)Summary page 6…k) Great Basin Stool Bacterial Pathogens Panel E. Substantial Equivalence Information: Predicate Device: Nanosphere Verigene® Enteric Pathogens Nucleic Acid Test (K140083) The following table provides a comparison of the Stool Bacterial Pathogens Panel and the predicate device:… | 2014 |
| † | K140407 | Filmarray Gastrointestinal (GI) Panel | 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 4 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All PCI devicesPCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PCI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCI
Too few PCI 510(k)s in any year since 2007 to give a median.
Recalls per year · PCI
No recall names PCI since 2007.
Adverse event reports per year · PCI
7in 2025
MAUDE reports naming product code PCI, 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 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens. The Stool Bacterial Pathogens Panel detects nucleic acids from: » Campylobacter (C. coli/C. jejuni) » Salmonella * Shiga toxin 1 (sfx1) * Shiga toxin 2 (stx2) * Escherichia coli serotype 0157 * Shigella Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC/EHEC/VTEC)…
Read the full statement (237 words)
The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens. The Stool Bacterial Pathogens Panel detects nucleic acids from:
» Campylobacter (C. coli/C. jejuni)
» Salmonella
* Shiga toxin 1 (sfx1)
* Shiga toxin 2 (stx2)
* Escherichia coli serotype 0157
* Shigella
Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC/EHEC/VTEC) and Shigella dysenteriae. The E. coli 0157 test result is only reported if a Shiga toxin gene (stx1 and/or stx2) is also detected.
The Stool Bacterial Pathogens Panel is performed directly from Cary Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis and is performed on the Portrait™ Analyzer.
The test is intended for use as an aid in the diagnosis of specific agents of gastrointestinal iliness in conjunction with clinical and epidemiological information; however, it is not to be used to monitor these infections. Positive results do not rule out co-infection with other organisms and may not be the definitive cause of patient illness. Negative test 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 cuiture is necessary if organism recovery or further typing of bacterial agents is desired.
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/K163571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163571: Great Basin Stool Bacterial Pathogens Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163571
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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