BÜHLMANN Laboratories AG, is proud to announce it received United States Food and Drug Administration (FDA) 510(k) clearance of its BÜHLMANN fCAL® turbo.
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.
Speed, Quality, Flexibility in Calprotectin Quantification
BÜHLMANN fCAL® turbo uses immunoturbidimetry technology, which implements further milestone in fecal calprotectin quantification. It allows very rapid and flexible random access use, as well as being the ideal solution for high throughput applications in the routine laboratory. Unique in speed, quality, and flexibility, this assay offers reliable information to aid clinicians in selecting patients for further diagnostic procedures.
Standardizing this test against the well established, FDA 510 (k) cleared, BÜHLMANN fCAL® ELISA, has generated a robust assay that is accurate, precise and efficient.
Focus on what really matters – calprotectin results you can stand behind. Increase your efficiency and cost savings with the fastest fCAL assay the FDA has registered.
- Short Analysis Time:
- Time to first result: 10 minutes
- Throughput: 192** results/hr (analyzer dependent)
- Reduction in re-runs: automated dilution ( measuring range of 20-8000 μg/g)
- Proven standardization:
- Outstanding AUCs:
BÜHLMANN fCAL® turbo Benefits
- Easy-to-use assay kit (first result within 10 minutes)
- Reagents are ready to use
- Reagent on board: stable for up to 60 days
- Kit includes calibrators and controls
- Analytical Sensitivity: <22 µg/g Calprotectin in fecal sample
- Measurable range 20-1800µg/g