# K232057: BÜHLMANN fCAL® turbo and CALEX® Cap

- Pathway: 510(k) (Special)
- Applicant: Bühlmann Laboratories AG
- Decided: Feb 6, 2024 after 210 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: 6 generations back to DEN060001 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191718: Buhlmann fCAL turbo and CALEX Cap, Buhlmann Laboratories AG (2019) Summary page 4.

## Indications for use
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo 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. The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL® turbo.

Source page: https://510kreport.com/device/K232057
Methodology: https://510kreport.com/methodology