510(k) · Cleared
ClearedBD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
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 Oct 31, 2025 as substantially equivalent to K140111 (Becton, Dickinson and Company, 2014) and 2 other predicates after a 266-day review. Its family tree reaches back 6 generations to 2013.
- Decided
- Oct 31, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- PCI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to DEN130003 (2013). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 5 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 4 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 3 generations backK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- 2 generations backK170308 BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company · 2017 · Recalled
- 1 generation backK214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial…Becton, Dickinson and Company · 2022
- This deviceK250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial…Becton, Dickinson and Company · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −5 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −4 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −3 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| −2 | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton, Dickinson and Company | 2017 | 1 |
| −1 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022 | — |
| 0 (this device) | 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 |
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 K214122 BD MAX Enteric Bacterial Panel, BD MAX…score 7.9 · 5 generations · no Class I recall
What was it cleared against? (3)
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 12…Proposed: BD Enteric Bacterial Predicate: BD MAX xEBP Proposed BD Enteric Bacterial Panel plus Item (K140111, K214122) Panel for BD COR™ System (K170308, K214122) for BD COR™… | 2014 |
| * | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelSummary page 7…Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens, November 2, 2015. Predicate Device BD MAX™ Enteric Bacterial Panel (K170308, K214122) and BD MAX™ Extended Enteric Bacterial Panel (K170308, K214122) Device Establishment Registration Number: 1119779 Intended Us… | 2022 |
| * | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX SystemSummary page 7…says for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens, November 2, 2015. Predicate Device BD MAX™ Enteric Bacterial Panel (K170308, K214122) and BD MAX™ Extended Enteric Bacterial Panel (K170308, K214122) Device Establishment Registration Number: 1119779 In… | 2017 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 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. 2025, 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 Enteric Bacterial Panel for BD COR™ System BD Enteric Bacterial Panel for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR™ System detects nucleic acids from: • Salmonella spp. • Campylobacter spp. (C. jejuni and C. coli) • Shigella spp. / Enteroinvasive Escherichia coli (EIEC) • Shiga toxin 1 (stx1) / Shiga toxin 2…
Read the full statement (728 words)
BD Enteric Bacterial Panel for BD COR™ System
BD Enteric Bacterial Panel for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel for BD COR™ System detects nucleic acids from:
• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia 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 utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. 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). 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 Enteric Bacterial Panel plus for BD COR™ System
BD Enteric Bacterial Panel plus for BD COR™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. BD Enteric Bacterial Panel plus for BD COR™ System detects nucleic acids from:
• Salmonella spp.
• Campylobacter spp. (C. jejuni and C. coli)
• Shigella spp. / Enteroinvasive Escherichia coli (EIEC)
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing Escherichia coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
• Plesiomonas shigelloides
• Vibrio spp. (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 utilizing the BD Fecal Collection and Transport Kit. Unpreserved soft to diarrheal stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis are probed using the flocked swab and material is transferred to the BD Fecal Collection and Transport tube containing modified Cary-Blair medium. The test is performed utilizing real-time polymerase chain reaction (PCR) for the amplification of specific sequences of target DNA. 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, Shiga toxin-producing E. coli (STEC), Plesiomonas shigelloides, Vibrio spp. (V. vulnificus, V. parahaemolyticus, and V. cholerae), Enterotoxigenic Escherichia coli (ETEC) LT/ST, and Yersinia enterocolitica. 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.
Enteric Bacterial Panel Diluent for BD COR™ System
The Enteric Bacterial Panel Diluent for BD COR™ System is intended to be used in clinical settings according to instructions provided for aliquoting into Molecular Aliquot Tubes by the BD COR™ System. The Enteric Bacterial Panel Diluent for BD COR™ System is only for use with BD Fecal Collection and Transport Kit specimens tested on BD COR™ Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250358: BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250358
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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