# DEN060001: Phical Test

- Pathway: De Novo (Post-NSE)
- Applicant: Genova Diagnostics
- Decided: Apr 26, 2006 after 34 days
- Product code: NXO (Calprotectin, Fecal)
- Device class: 2
- Regulation: 21 CFR 866.5180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K130945: Calprest (2014), 10 descendants of its own
- K160447: Calprest NG (2016), 8 descendants of its own
- K181012: BUHLMANN fCAL ELISA (2018), 3 descendants of its own
- K190784: BUHLMANN fCAL turbo (2019), 2 descendants of its own
- K191718: Buhlmann fCAL turbo and CALEX Cap (2019), 1 descendant of its own

Source page: https://510kreport.com/device/DEN060001
Methodology: https://510kreport.com/methodology