510(k) · Cleared
ClearedBD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jul 28, 2022 as substantially equivalent to K140111 (Becton, Dickinson and Company, 2014) and 1 other predicate after a 210-day review. Its family tree reaches back 5 generations to 2013. 1 later device descends from it.
- Decided
- Jul 28, 2022
- Review
- 210 days
- Class
- Class II
- Product code
- PCI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN130003 (2013). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 4 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 3 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 2 generations backK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- 1 generation backK170308 BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company · 2017 · Recalled
- This deviceK214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial…Becton, Dickinson and Company · 2022
- Descendant · cites it directly · 0 of its ownK250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial…Becton, Dickinson and Company · 2025
Most influential descendants
Showing 1 of 1 · See all- K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −4 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −3 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −2 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| −1 | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton, Dickinson and Company | 2017 | 1 |
| 0 (this device) | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022 | — |
| +1 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus… | Becton, Dickinson and Company | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentSummary page 6…l Pathogen Panel Multiplex Nucleic Acid-Based Assay System OOI Real Time Nucleic Acid Amplification System Predicate Device BD MAX™ Enteric Bacterial Panel (K140111) BD MAX™ Extended Enteric Bacterial Panel (K170308) Device Establishment Becton, Dickinson and Company 7 Loveton Circle Sparks,… | 2014 |
| * | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX SystemSummary page 6…System OOI Real Time Nucleic Acid Amplification System Predicate Device BD MAX™ Enteric Bacterial Panel (K140111) BD MAX™ Extended Enteric Bacterial Panel (K170308) Device Establishment Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779 Performance… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR… | 2025 | 0 |
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 1.1 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K250358 (Becton, Dickinson and Company, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140111.
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. 2022, 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?
BD MAX™ Enteric Bacterial Panel The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX™ Enteric Bacterial Panel detects nucleic acids from: • Salmonella spp. • Campylobacter spp. (jejuni and coli) • Shigella spp. / Enteroinvasive E. coli (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found…
Read the full statement (570 words)
BD MAX™ Enteric Bacterial Panel
The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX™ Enteric Bacterial Panel detects nucleic acids from:
• Salmonella spp.
• Campylobacter spp. (jejuni and coli)
• Shigella spp. / Enteroinvasive E. coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
Testing is performed on unpreserved soft to diarrheal stool specimens 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 SpaO, a Campylobacter specific tuf gene sequence, ipaH and stx1/stx2. The test utilizes fluorogenic sequence-specific hybridization probes for 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 Salmonella, Shigella/EIEC, Campylobacter and Shiga toxin-producing E. coli (STEC) 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.
BD MAX™ Extended Enteric Bacterial Panel
The BD MAX™ Extended Enteric Bacterial Panel performed on the BD MAX™ System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. It is used in conjunction with the BD MAX™ Enteric Bacterial Panel as an optional Master Mix. The BD MAX™ Extended Enteric Bacterial Panel detects nucleic acids from:
• Plesiomonas shigelloides
• Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae)
• Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes
• Yersinia enterocolitica
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. 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 Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae) Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica 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 as stated in the FDA summary.
https://510kreport.com/device/K214122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214122
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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