510(k) · Cleared
ClearedQIAstat-Dx Gastrointestinal Panel 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on May 31, 2024 as substantially equivalent to K140407 (Biofire Diagnostics, 2014) after an 872-day review. Its family tree reaches back 2 generations to 2013. 4 later devices descend from it.
- Decided
- May 31, 2024
- Review
- 872 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130003 (2013). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK220062 QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH · 2024
- Descendant · cites it directly · 2 of its ownK250324 QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2025
- Descendant · cites it directly · 2 of its ownK243813 QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH · 2025
- Descendant · cites it directly · 1 of its ownK252329 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V…QIAGEN GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK254032 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V…QIAGEN GmbH · 2026
Most influential descendants
Showing 4 of 4 · See all- K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2025 · cites it directly2descendants
- K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH · 2025 · cites it directly2descendants
- K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH · 2025 · cites it directly1descendant
- K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH · 2026 · 2 generations on0descendants
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) | K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024 | — |
| +1 | K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025 | — |
| +1 | K243813 | QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH | 2025 | — |
| +1 | K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V… | QIAGEN GmbH | 2025 | — |
| +2 | K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V… | QIAGEN GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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 K242367 BIOFIRE FILMARRAY Gastrointestinal (GI) Panelscore 15.5 · 5 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 5…PCH Predicate Device Manufacturer Product Name 510(k) No. BioFire Diagnostics LLC FilmArray® K140407 Gastrointestinal (GI) Panel QIAGEN… | 2014 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K250324 (QIAGEN GmbH, 2025) has gone furthest, with 2 descendants of its own.
- 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. 2024, 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 QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including…
Read the full statement (309 words)
The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. coli/Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2 :
Pathogen Para-Pak C&S FecalSwab
* Adenovirus F40/F41 Reported Reported
* Astrovirus Reported Reported
* Norovirus GI/GI1 Reported Reported
* Rotavirus A Reported Reported
» Campylobacter (C. jejuni, C. coli and C. upsaliensis) Reported Reported
» Shigella/Enteroinvasive Escherichia coli (EIEC) Reported Reported
* Enteropathogenic Escherichia coli (EPEC) Reported Not Reported
* Enterotoxigenic Escherichia coli (ETEC) It/st Reported Reported
» Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 Reported Not Reported
(including specific identification of E. coli O157 serogroup within STEC)
* Salmonella Reported Reported
* Plesiomonas shigelloides Reported Reported
* Yersinia enterocolitica Reported Reported
* Cryptosporidium Reported Reported
* Cyclospora cayetanensis Reported Reported
* Entamoeba histolytica Reported Reported
* Giardia lamblia* Reported Reported
*(Also known as Giardia intestinalis and Giardia duodenalis)
Concomitant culture is necessary for organism recovery and further typing of bacterial agents.
The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease.
Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay 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/K220062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220062: QIAstat-Dx Gastrointestinal Panel 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220062
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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