# K160447: Calprest NG

- Pathway: 510(k) (Traditional)
- Applicant: Eurospital S.P.A.
- Decided: Nov 10, 2016 after 267 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.
8 later devices descend from it; 4 cite it directly.
0 of 11 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 4.

## Most influential descendants
- 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
- K232057: BÜHLMANN fCAL® turbo and CALEX® Cap (2024), 0 descendants of its own

## Indications for use
Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically 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/K160447
Methodology: https://510kreport.com/methodology