510(k) · Cleared
ClearedGreat Basin Shiga Toxin Direct Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Basin Scientific, Inc. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Mar 22, 2016 as substantially equivalent to K140407 (Biofire Diagnostics, 2014) after a 167-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Mar 22, 2016
- Review
- 167 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.
- Root · 2 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 1 generation backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- This deviceK152955 Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −1 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| 0 (this device) | K152955 | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | 2016 | — |
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 6…antial Equivalence Information: a. Predicate Device: FilmArray® Gastrointestinal (GI) Panel from BioFire Diagnostics, LLC b. Predicate 510(k) number: K140407 c. Comparison with Predicate, see chart: Predicate Device Comparison Cha… | 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 3 years and passes through 3 companies; a new generation was cleared every 1.9 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. 2016, 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 Great Basin Shiga Toxin Direct Test performed on the Portrait™ Analyzer is an automated, in vitro diagnostic assay for the qualitative detection of Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes and specific identification of a conserved genetic region of the E. coli O157 serogroup. Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC) and Shigella dysenteriae. The E. coli O157 test result is reported only if a Shiga toxin…
Read the full statement (210 words)
The Great Basin Shiga Toxin Direct Test performed on the Portrait™ Analyzer is an automated, in vitro diagnostic assay for the qualitative detection of Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes and specific identification of a conserved genetic region of the E. coli O157 serogroup. Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC) and Shigella dysenteriae. The E. coli O157 test result is reported only if a Shiga toxin gene is also detected.
The test is performed directly from Cary-Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis in hospital laboratories. The assay is intended for use in conjunction with clinical presentation as an aid in the diagnosis of STEC infections. Positive results do not rule out co-infection with other organisms, and may not be the definitive cause of patient illness.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Shiga Toxin Direct Test 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/K152955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152955: Great Basin Shiga Toxin Direct Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152955
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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