# 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

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 31, 2025 after 266 days
- Product code: PCI (Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN130003 (2013). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140111: BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument, Becton, Dickinson and Company (2014) Summary page 12.
- K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel, Becton, Dickinson and Company (2022) Summary page 7.
- K170308: BD MAX Extended Enteric Bacterial Panel, BD MAX System, Becton, Dickinson and Company (2017) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K250358
Methodology: https://510kreport.com/methodology