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 Jan 10, 2025 as substantially equivalent to K190585 (Applied BioCode, Inc., 2019) after a 109-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Jan 10, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130003 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 2 generations backK180041 BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2018
- 1 generation backK190585 Biocode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2019
- This deviceK242877 BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −2 | K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2018 | — |
| −1 | K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2019 | — |
| 0 (this device) | K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K190585 | Biocode Gastrointestinal Pathogen Panel (GPP)Summary page 6…fication Gastrointestinal microorganism multiplex nucleic acid-based assay Name Regulation 21 CFR § 866.3990 Predicate Device [807.92(a)(3)] K190585 BioCode Gastrointestinal Pathogen Panel (GPP) Device Description [807.92(a)(4)] The BioCode® Gastrointestinal Patho… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
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. 2025, 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 multiplexed nucleic acid-based in vitro diagnostic test intended for use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved stool samples or stool preserved in Cary-Blair transport medium obtained from individuals with signs…
Read the full statement (374 words)
The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for
use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection and identification of nucleic
acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved stool samples or stool preserved in Cary-Blair
transport medium obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria, parasites,
and viruses are identified using the BioCode Gastrointestinal Pathogen Panel:
▪ Campylobacter (C. jejuni/C. coli)
▪ Clostridium difficile (C. difficile) toxin A/B (Fresh samples only)
▪ Salmonella spp
▪ Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio parahaemolyticus
▪ Yersinia enterocolitica
▪ Enteroaggregative Escherichia coli (EAEC)
▪ Enterotoxigenic Escherichia coli (ETEC) lt/st
▪ E. coli O157 serogroup
▪ Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2
▪ Shigella/ Enteroinvasive Escherichia coli (EIEC)
▪ Cryptosporidium spp (C. parvum/C. hominis)
▪ Entamoeba histolytica
▪ Giardia lamblia (also known as G. intestinalis and G. duodenalis)
▪ Adenovirus F 40/41
▪ Norovirus GI/GII
▪ Rotavirus A
The BioCode 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. For In Vitro Diagnostic Use Only. For Prescription Use Only.
Positive results do not rule out co-infection with organisms not included in the BioCode GPP. The agent detected may not be the
definite cause of the disease. 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 Adenovirus 40/41, Campylobacter, E. coli O157, Shigella/EIEC, Yersinia enterocolitica, and Giardia lamblia were
established additionally with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, Giardia lamblia,
Yersinia enterocolitica and Vibrio (V. parahaemolyticus, V. vulnificus, and V. 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/K242877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242877: BioCode Gastrointestinal Pathogen Panel (GPP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242877
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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