# K130945: Calprest

- Pathway: 510(k) (Traditional)
- Applicant: Eurospital S.P.A.
- Decided: Jan 16, 2014 after 287 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
Longest line of descent: 1 generation back to DEN060001 (2006). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN060001: Phical Test, Genova Diagnostics (2006). Our reading of the summary gave K050007, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060001, Phical Test (Genova Diagnostics), granted Apr 26, 2006; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- 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
- K170993: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (2017), 1 descendant of its own

## Indications for use
Calprest® is a quantitative ELISA for detecting the concentration of fecal calprotectin. Calprest® can be used as an in-vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and other laboratory findings.

Source page: https://510kreport.com/device/K130945
Methodology: https://510kreport.com/methodology