# K220193: BD MAX Enteric Parasite Panel

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 19, 2022 after 207 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: 3 generations back to DEN130003 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143648: BD MAX Enteric Parasite Panel, BD MAX Instrument, Becton, Dickinson and Company (2015) Summary page 5.

## Indications for use
The BD MAX Enteric Parasite Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection of enteric parasitic pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from: Giardia lamblia Cryptosporidium (C. hominis and C. parvum only), Entamoeba histolytica Testing is performed on unpreserved or 10% formalin-fixed stool specimens or FecalSwab specimens from symptomatic patients with suspected gastroenteritis, enteritis, or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real- time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-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 Giardia lamblia, Cryptosporidium hominis, and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. 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 and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as colitis, irritable bowel syndrome, or Crohn’s disease.

Source page: https://510kreport.com/device/K220193
Methodology: https://510kreport.com/methodology