# K191589: Calprest, EasyCal

- Pathway: 510(k) (Special)
- Applicant: Eurospital S.P.A.
- Decided: Jul 10, 2019 after 26 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: 2 generations back to DEN060001 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130945: Calprest, Eurospital S.P.A. (2014) Summary page 5.

## Indications for use
Calprest is a quantitative ELISA for detecting 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 laboratory findings.

Source page: https://510kreport.com/device/K191589
Methodology: https://510kreport.com/methodology