510(k) · Cleared
Recalled · Class II · 2019BD MAX Enteric Parasite Panel, BD MAX Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Aug 25, 2015 as substantially equivalent to K140407 (Biofire Diagnostics, 2014) after a 246-day review. Its family tree reaches back 2 generations to 2013. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 2015
- Review
- 246 days
- Class
- Class II
- Product code
- PCH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130003 (2013). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 1 generation backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- This deviceK143648 BD MAX Enteric Parasite Panel, BD MAX InstrumentBecton, Dickinson and Company · 2015
- Descendant · cites it directly · 0 of its ownK232672 EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited · 2024
- Descendant · cites it directly · 0 of its ownK220193 BD MAX Enteric Parasite PanelBecton, Dickinson and Company · 2022
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 |
|---|---|---|---|---|---|
| −2 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −1 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| 0 (this device) | K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | Becton, Dickinson and Company | 2015 | — |
| +1 | K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | 2024 | — |
| +1 | K220193 | BD MAX Enteric Parasite Panel | Becton, Dickinson and Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K140407 | Filmarray Gastrointestinal (GI) PanelSummary page 5…y (83) Product Code(s): PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Predicate Device FilmArray Gastrointestinal (GI) Panel Kit [K140407 (May 2, 2014)], BioFire Diagnostics, LLC Device Establishment GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. du Parc… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Class II | Z-2329-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K232672 (Genetic Signatures Limited, 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K140407.
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. 2015, 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 BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric parasitic pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from: • Giardia lamblia • Cryptosporidium (C. hominis and C. parvum only) • Entamoeba histolytica Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected…
Read the full statement (253 words)
The BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric parasitic pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from:
• Giardia lamblia
• Cryptosporidium (C. hominis and C. parvum only)
• Entamoeba histolytica
Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-specific hybridization probes for detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Giardia lamblia, Cryptosporidium hominis and C. parvum, as well as Entamoeba histolytica infections. 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 be 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 as stated in the FDA summary.
https://510kreport.com/device/K143648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143648: BD MAX Enteric Parasite Panel, BD MAX Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143648
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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