# K123274: Progastro SSCS Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Jan 16, 2013 after 89 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: 1 generation back to DEN130003 (2013). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas), Luminex Molecular Diagnostics, Inc. (2013). Our reading of the summary gave K121454, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130003, Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data… (Luminex Molecular Diagnostics, Inc.), granted Jan 14, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K140111: BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument (2014), 3 descendants of its own
- K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (2022), 1 descendant of its own
- K250358: BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System (2025), 0 descendants of its own
- K173330: PanNAT STEC Test (2018), 0 descendants of its own

## Indications for use
The Prodesse ProGastro SSCS Assay is a multiplex real time PCR in vitro diagnostic test for the qualitative detection and differentiation of Salmonella, Shigella, and Campylobacter (C. jejuni and C. coli only, undifferentiated) nucleic acids and Shiga Toxin 1 (stx1) and Shiga Toxin 2 (stx2) genes. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. Nucleic acids are isolated and purified from preserved stool specimens obtained from symptomatic patients exhibiting signs and symptoms of gastroenteritis. This test is intended for use, in conjunction with clinical presentation and epidemiological risk factors, as an aid in the differential diagnosis of Salmonella, Shigella, Campylobacter jejuni/Campylobacter coli, and STEC infections in humans. The 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 ProGastro SSCS 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/K123274
Methodology: https://510kreport.com/methodology