# K181012: BUHLMANN fCAL ELISA

- Pathway: 510(k) (Traditional)
- Applicant: Buhlmann Laboratories AG
- Decided: Jun 4, 2018 after 48 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: 3 generations back to DEN060001 (2006). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160447: Calprest NG, Eurospital S.P.A. (2016) Summary page 4.

## Most influential descendants
- K190784: BUHLMANN fCAL turbo (2019), 2 descendants of its own
- K191718: Buhlmann fCAL turbo and CALEX Cap (2019), 1 descendant of its own
- K232057: BÜHLMANN fCAL® turbo and CALEX® Cap (2024), 0 descendants of its own

## Indications for use
The BÜHLMANN fCAL® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL® ELISA aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K181012
Methodology: https://510kreport.com/methodology