510(k) · Cleared
ClearedProgastro SSCS Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe Prodesse, Inc. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jan 16, 2013 as substantially equivalent to DEN130003 (Luminex Molecular Diagnostics, Inc., 2013) after an 89-day review. Its family tree reaches back 1 generation to 2013. 4 later devices descend from it.
- Decided
- Jan 16, 2013
- Review
- 89 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130003 (2013). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- This deviceK123274 Progastro SSCS AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK140111 BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial…Becton, Dickinson and Company · 2022
- Descendant · 2 generations on · 0 of its ownK250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial…Becton, Dickinson and Company · 2025
- Descendant · 2 generations on · 0 of its ownK173330 PanNAT STEC TestMicronics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K140111BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company · 2014 · cites it directly3descendants
- K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company · 2022 · 2 generations on1descendant
- K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company · 2025 · 2 generations on0descendants
- K173330PanNAT STEC TestMicronics, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K123274 | Progastro SSCS Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +1 | K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument | Becton, Dickinson and Company | 2014 | 2 |
| +2 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022 | — |
| +2 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus… | Becton, Dickinson and Company | 2025 | — |
| +2 | K173330 | PanNAT STEC Test | Micronics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCH device
- #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas) 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. | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PCH devicesPCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PCH
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCH
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCH
5in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCH
40in 2025
MAUDE reports naming product code PCH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | — | 0 | 0 |
| 2014 | 6 | 120 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 105 | 0 | 0 |
| 2019 | 4 | 191 | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 2 | — | 0 | 47 |
| 2023 | 1 | — | 1 | 62 |
| 2024 | 3 | 271 | 0 | 45 |
| 2025 | 7 | 89 | 5 | 40 |
| 2026 | 3 | 176 | 0 | — |
What is it indicated for?
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…
Read the full statement (210 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123274: Progastro SSCS Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026