510(k) · Cleared
ClearedEasyScreen Gastrointestinal Parasite Detection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genetic Signatures Limited · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on May 29, 2024 as substantially equivalent to K143648 (Becton, Dickinson and Company, 2015) after a 271-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- May 29, 2024
- Review
- 271 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 backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 1 generation backK143648 BD MAX Enteric Parasite Panel, BD MAX InstrumentBecton, Dickinson and Company · 2015 · Recalled
- This deviceK232672 EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited · 2024
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 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −1 | K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | Becton, Dickinson and Company | 2015 | 1 |
| 0 (this device) | K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | 2024 | — |
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 |
|---|---|---|---|
| * | K143648 | BD MAX Enteric Parasite Panel, BD MAX InstrumentSummary page 5…Class II Predicate Device Predicate Device: BD MAX™ Enteric Parasite Panel (EPP) Predicate 510(k): K143648 Predicate Product Code(s): PCH (Class 2) – Gastrointestinal Pathogen Panel… | 2015 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K143648.
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. 2024, 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 Genetic Signatures EasyScreen TM Gastrointestinal Parasite Detection Kit is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR, detects the nucleic acid of the following organisms: * Cryptosporidium spp. * Giardia intestinalis * Dientamoeba fragilis * Entamoeba…
Read the full statement (381 words)
The Genetic Signatures EasyScreen TM Gastrointestinal Parasite Detection Kit is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR, detects the nucleic acid of the following organisms:
* Cryptosporidium spp.
* Giardia intestinalis
* Dientamoeba fragilis
* Entamoeba histolytica
* Blastocystis hominis
* Enterocytozoon bieneusi
* Encephalitozoon intestinalis
* Cyclospora cayetanensis
The kit is compatible with stool specimens that are unpreserved or frozen or in transport media including Cary Blair or C&S media from symptomatic patients with suspected gastroenteritis. It is required that the stool is first processed using the EasyScreenTM Sample Processing Kit. Nucleic acid extraction and real-time PCR set up are performed on the automated Genetic Signatures GS1 platform.
The EasyScreenTM Gastrointestinal Parasite Detection Kit includes all reagents required to detect the specific protozoan gene sequences using real-time PCR amplification of the extracted nucleic acids and fluorogenic target-specific hybridization probes for the detection of the amplified nucleic acid. The EasyScreen TM Gastrointestinal Parasite Detection kit also incorporates an Extraction Control (EC) and an Internal Positive Control (IPC) to ensure the reliability of the extracted nucleic acid and to detect the presence of any inhibitors, respectively.
This device is an in vitro diagnostic (IVD) intended to be used by trained personnel in clinical, pathology or hospital laboratories as an aid in the diagnosis of gastrointestinal illness. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of infections by Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon bieneusi, Cyclospora cayetanensis, Entamoeba histolytica, Encephalitozoon intestinalis, Cryptosporidium spp. (including C. hominis and C. parvum), and Giardia intestinalis. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not indicate the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis and/or colitis 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/K232672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232672: EasyScreen Gastrointestinal Parasite Detection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232672
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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