# K163571: Great Basin Stool Bacterial Pathogens Panel

- Pathway: 510(k) (Traditional)
- Applicant: Great Basin Scientific, Inc.
- Decided: Jul 12, 2017 after 205 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K121894 (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)
- K140083: Verigene Enteric Pathogen Nucleic Acid Test ( EP), Nanosphere, Inc. (2014) Summary page 6.

## Indications for use
The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens. The Stool Bacterial Pathogens Panel detects nucleic acids from: » Campylobacter (C. coli/C. jejuni) » Salmonella * Shiga toxin 1 (sfx1) * Shiga toxin 2 (stx2) * Escherichia coli serotype 0157 * Shigella Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC/EHEC/VTEC) and Shigella dysenteriae. The E. coli 0157 test result is only reported if a Shiga toxin gene (stx1 and/or stx2) is also detected. The Stool Bacterial Pathogens Panel is performed directly from Cary Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis and is performed on the Portrait™ Analyzer. The test is intended for use as an aid in the diagnosis of specific agents of gastrointestinal iliness in conjunction with clinical and epidemiological information; however, it is not to be used to monitor these infections. Positive results do not rule out co-infection with other organisms and may not be the definitive cause of patient illness. Negative test 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. Concomitant cuiture is necessary if organism recovery or further typing of bacterial agents is desired.

Source page: https://510kreport.com/device/K163571
Methodology: https://510kreport.com/methodology