De Novo · Granted
GrantedPhical Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genova Diagnostics · NXO Calprotectin, Fecal
Granted on Apr 26, 2006 as a new device type through De Novo after a 34-day review. 13 later devices descend from it.
- Decided
- Apr 26, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
13 later devices descend from it, 2 citing it directly.
- This deviceDEN060001 Phical TestGenova Diagnostics · 2006
- Descendant · cites it directly · 10 of its ownK130945 CalprestEurospital S.P.A. · 2014
- Descendant · 2 generations on · 8 of its ownK160447 Calprest NGEurospital S.P.A. · 2016
- Descendant · 3 generations on · 3 of its ownK181012 BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018
- Descendant · 4 generations on · 2 of its ownK190784 BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019
- Descendant · 5 generations on · 1 of its ownK191718 Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130945CalprestEurospital S.P.A. · 2014 · cites it directly10descendants
- K160447Calprest NGEurospital S.P.A. · 2016 · 2 generations on8descendants
- K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018 · 3 generations on3descendants
- K190784BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019 · 4 generations on2descendants
- K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| +1 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| +2 | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| +3 | K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018 | — |
| +4 | K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019 | — |
| +5 | K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXO? 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 NXO device
- #1 K232057 BÜHLMANN fCAL® turbo and CALEX® Capscore 8.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (13)
See all 132 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130945 (Eurospital S.P.A., 2014) has gone furthest, with 10 descendants of its own.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NXO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NXO
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXO
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXO
1in 2022
MAUDE reports naming product code NXO, 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 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 5 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN060001 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN060001: Phical Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN060001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026