510(k) · Cleared
ClearedBioCode Gastrointestinal Pathogen Panel (GPP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied BioCode, Inc. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Sep 28, 2018 as substantially equivalent to DEN130003 (Luminex Molecular Diagnostics, Inc., 2013) after a 266-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Sep 28, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130003 (2013). 2 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 deviceK180041 BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK190585 Biocode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK242877 BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2018 | — |
| +1 | K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2019 | — |
| +2 | K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | 2019 | 1 |
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. 2018, 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 BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative, gastrointestinal microorganism multiplexed nucleic acid-based assay capable of detecting of nucleic acids from the following organisms in unpreserved stool and Cary-Blair media: • Adenovirus 40/41 • Campylobacter (C. jejuni, C. coli) • Clostridium difficile (C. difficile) toxin A/B (from fresh specimens only) • Cryptosporidium (C. parvum, C. hominis) • Entamoeba histolytica • Escherichia…
Read the full statement (322 words)
The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative, gastrointestinal microorganism
multiplexed nucleic acid-based assay capable of detecting of nucleic acids from the following organisms in
unpreserved stool and Cary-Blair media:
• Adenovirus 40/41
• Campylobacter (C. jejuni, C. coli)
• Clostridium difficile (C. difficile) toxin A/B (from fresh specimens only)
• Cryptosporidium (C. parvum, C. hominis)
• Entamoeba histolytica
• Escherichia coli (E. coli) O157
• Enterotoxigenic E. coli (ETEC) LT/ST
• Enteroaggregative E. coli (EAEC)
• Giardia lamblia (also known as G. intestinalis and G. duodenalis)
• Norovirus GI/GII
• Rotavirus A
• Salmonella spp.
• Shiga-like Toxin producing E. coli (STEC) stx1/stx2
• Shigella (S. boydii, S. sonnei, S. flexneri, S. dysenteriae)/EIEC
• Vibrio spp. (V. cholerae, V. parahaemolyticus, V. vulnificus), specific identification of V.
parahaemolyticus
• Yersinia enterocolitica
The BioCode Gastrointestinal Pathogen Panel (GPP) is indicated as an aid in the diagnosis of specific agents of
gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and
epidemiological data. Positive results do not rule out co-infection with organisms not included in the BioCode
Gastrointestinal Pathogen Panel (GPP). The agent detected may not be the cause of patient illness. 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.
Concomitant culture is necessary for organism recovery and further typing of bacterial agents.
This device is not intended to monitor or guide treatment for C. difficile infection.
Due to the small number of positive specimens collected for certain organisms during the prospective clinical
study, performance characteristics for Campylobacter spp., E. coli O157, Shigella/EIEC, Yersinia
enterocolitica, and Adenovirus 40/41 were established primarily with retrospective clinical specimens.
Performance characteristics for Entamoeba histolytica, and Vibrio spp. (V. parahaemolyticus, V. vulnificus,
and Vibrio cholerae) were established primarily using contrived clinical specimens.
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/K180041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180041: BioCode Gastrointestinal Pathogen Panel (GPP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180041
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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