# K220607: BD MAX Enteric Viral Panel

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 21, 2022 after 203 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: none
- 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181427: BD MAX Enteric Viral Panel, BD MAX Instrument, Becton, Dickinson and Company (2018) Summary page 5.

## Indications for use
The BD MAX™ Enteric Viral Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens. The BD MAX™ Enteric Viral Panel detects nucleic acids from * Norovirus GI & GII * Rotavirus A * Adenovirus F40/41 » Sapovirus (genogroups L, IL, IV, V) * Human Astrovirus (hAstro) 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/RNA. 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 Norovirus GI & GlII, Rotavirus A, Adenovirus F40/41, Sapovirus (genogroups L, I, IV, V), and Astrovirus 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/K220607
Methodology: https://510kreport.com/methodology