# K170308: BD MAX Extended Enteric Bacterial Panel, BD MAX System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: May 2, 2017 after 90 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130003 (2013). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch, Biofire Diagnostics, LLC (2016) Summary page 5.

## Most influential descendants
- K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (2022), 1 descendant of its own
- 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

## Recalls of this device
- Jul 17, 2019 · Class II · Z-2338-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

## Indications for use
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 e Plesiomonas shigelloides e Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae) e Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes e Yersinia enterocolitica Testing is performed on soft to diarrheal unpreserved 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 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/K170308
Methodology: https://510kreport.com/methodology