510(k) · Cleared
ClearedBD MAX Enteric Viral Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Sep 21, 2022 as substantially equivalent to K181427 (Becton, Dickinson and Company, 2018) after a 203-day review. Its family tree reaches back 4 generations to 2013.
- Decided
- Sep 21, 2022
- Review
- 203 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130003 (2013). No later device cites it as a predicate yet.
- Root · 4 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 3 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 2 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 1 generation backK181427 BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company · 2018 · Recalled
- This deviceK220607 BD MAX Enteric Viral PanelBecton, Dickinson and Company · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −3 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −2 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −1 | K181427 | BD MAX Enteric Viral Panel, BD MAX Instrument | Becton, Dickinson and Company | 2018 | 1 |
| 0 (this device) | K220607 | BD MAX Enteric Viral Panel | Becton, Dickinson and Company | 2022 | — |
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 |
|---|---|---|---|
| * | K181427 | BD MAX Enteric Viral Panel, BD MAX InstrumentSummary page 5…astrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System OOI – Real Time Nucleic Acid Amplification System Predicate Device BD MAX™ Enteric Viral Panel (K181427) Device Establishment Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779 Performance… | 2018 |
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 9 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
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. 2022, 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 BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from * Norovirus GI & GII * Rotavirus A * Adenovirus F40/41 » Sapovirus (genogroups L, IL, IV, V) * Human Astrovirus (hAstro) Testing is performed on unpreserved soft to diarrheal or Cary-Blair preserved stool…
Read the full statement (249 words)
The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from
* Norovirus GI & GII
* Rotavirus A
* Adenovirus F40/41
» Sapovirus (genogroups L, IL, IV, V)
* Human Astrovirus (hAstro)
Testing is performed on unpreserved soft to diarrheal or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of relevant gene target DNA/RNA. The test utilizes fluorogenic gene-specific hybridization probes for the detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Norovirus GI & GlII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups L, I, IV, V), and Astrovirus infections. Results of this test 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 other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. 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/K220607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220607: BD MAX Enteric Viral Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220607
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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