# K152955: Great Basin Shiga Toxin Direct Test

- Pathway: 510(k) (Traditional)
- Applicant: Great Basin Scientific, Inc.
- Decided: Mar 22, 2016 after 167 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 6.

## Indications for use
The Great Basin Shiga Toxin Direct Test performed on the Portrait™ Analyzer is an automated, in vitro diagnostic assay for the qualitative detection of Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes and specific identification of a conserved genetic region of the E. coli O157 serogroup. Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC) and Shigella dysenteriae. The E. coli O157 test result is reported only if a Shiga toxin gene is also detected. The test is performed directly from Cary-Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis in hospital laboratories. The assay is intended for use in conjunction with clinical presentation as an aid in the diagnosis of STEC infections. Positive results do not rule out co-infection with other organisms, and may not be the definitive cause of patient illness. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Shiga Toxin Direct Test 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/K152955
Methodology: https://510kreport.com/methodology