# K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 28, 2022 after 210 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: 5 generations back to DEN130003 (2013). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 6.
- K170308: BD MAX Extended Enteric Bacterial Panel, BD MAX System, Becton, Dickinson and Company (2017) Summary page 6.

## Most influential descendants
- 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 (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K214122
Methodology: https://510kreport.com/methodology