# K182703: EntericBio Dx Assay

- Pathway: 510(k) (Traditional)
- Applicant: Serosep, Ltd.
- Decided: Jun 19, 2019 after 265 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: 2 generations back to DEN130003 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140407: Filmarray Gastrointestinal (GI) Panel, Biofire Diagnostics (2014) Summary page 4.

## Indications for use
The EntericBio® Dx assay, performed on ABI 7500 Fast Dx real-time instrument, is an in vitro multiplexed nucleic acid test for the direct, simultaneous, qualitative detection and identification of multiple enteric pathogens in Cary-Blair preserved stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. The test is based on detection of nucleic acids from: • Salmonella enterica spp. • Shigella spp./ Enteroinvasive E. coli (EIEC) • Campylobacter spp. (jejuni, coli and lari) • STEC (Shiga-like toxin-producing E. coli), stx1/stx2 genes • Vibrio spp. (cholerae and parahaemolyticus) • Giardia lamblia (also known as G. intestinalis and G. duodenalis) • Entamoeba histolytica Testing is performed on Cary-Blair preserved diarrheal specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis of bacterial or parasitic origin. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of Salmonella-specific, Campylobacter-specific, Shigella/ EIEC-specific ipaH, stx1/stx2, Vibrio-specific, Entamoeba-specific and Giardia-specific gene sequences. The test utilizes fluorogenic sequence-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 diagnosis of Salmonella, Shigella / EIEC, Shiga-like toxin-producing E. coli, Campylobacter spp., Vibrio spp., Entamoeba histolytica and Giardia spp. infections in humans. 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 EntericBio® Dx assay 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/K182703
Methodology: https://510kreport.com/methodology