# K140111: BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: May 6, 2014 after 111 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130003 (2013). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123274: Progastro SSCS Assay, Gen-Probe Prodesse, Inc. (2013) Summary page 1.

## 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
- K173330: PanNAT STEC Test (2018), 0 descendants of its own

## Recalls of this device
- Jul 17, 2019 · Class II · Z-2330-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Jan 14, 2019 · Class II · Z-0981-2019: 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 Extende

## Indications for use
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.

Source page: https://510kreport.com/device/K140111
Methodology: https://510kreport.com/methodology