510(k) · Cleared
Recalled · Class II · 2019BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument
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 May 6, 2014 as substantially equivalent to K123274 (Gen-Probe Prodesse, Inc., 2013) after a 111-day review. Its family tree reaches back 2 generations to 2013. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 6, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- PCI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130003 (2013). 3 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 backK123274 Progastro SSCS AssayGen-Probe Prodesse, Inc. · 2013
- This deviceK140111 BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company · 2014
- Descendant · cites it directly · 1 of its ownK214122 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
- Descendant · cites it directly · 0 of its ownK173330 PanNAT STEC TestMicronics, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company · 2022 · cites it directly1descendant
- K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company · 2025 · cites it directly0descendants
- K173330PanNAT STEC TestMicronics, Inc. · 2018 · cites it directly0descendants
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 | K123274 | Progastro SSCS Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| 0 (this device) | K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument | Becton, Dickinson and Company | 2014 | — |
| +1 | 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 | — |
| +1 | K173330 | PanNAT STEC Test | Micronics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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
- #2 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 |
|---|---|---|---|
| * | K123274 | Progastro SSCS AssaySummary page 1…Microbiology (83) Predicate Device: Gen-Probe Prodesse, Inc. ProGastro SSCS Assay Predicate 510(k) Numbers: K123274 Intended Use The BID MAX TM Enteric Bacterial Panel performed on the BID MAX T M System is an automated in vitro diagnostic test… | 2013 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Class II | Z-2330-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| Jan 14, 2019 | Class II | Z-0981-2019 | Nonconforming Material/Component | False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K214122 (Becton, Dickinson and Company, 2022) has gone furthest, with 1 descendant of its own.
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. 2014, 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?
The BD MAXtm 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 BID MAX Enteric Bacterial Panel detects nucleic acids from: *Salmonella spp. *Campylobacter spp. (jejuni and coil) *Shigellar spp. / Enteroinvasive E. coil (EIEC) *Shiga toxin I (stxl) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli…
Read the full statement (280 words)
The BD MAXtm 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 BID MAX Enteric Bacterial Panel detects nucleic acids from:
*Salmonella spp.
*Campylobacter spp. (jejuni and coil)
*Shigellar spp. / Enteroinvasive E. coil (EIEC)
*Shiga toxin I (stxl) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC] as well as Shigella dysenterice, which can possess a Shiga toxin gene (stx) that is identical to the stxl gene of ST EC.
Testing is performed on unpreserved soft to diarrheil stool specimens or Gary-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 polymnerase chain reaction (PCR) for the amplification of SpaG, a Campy/obacter specific tufgene sequence, ipafl and stxl/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/EEC, Camp yiobacter and Shiga toxin-producing C.coli (STEC) infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient managemnent decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test, arid 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/K140111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140111: BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140111
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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