The Fecal Calprotectin Immunological Test System is a diagnostic tool used to measure calprotectin levels in stool samples. Calprotectin is a protein that is elevated in the presence of inflammation, particularly in conditions such as inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. This test helps in diagnosing and monitoring such conditions by detecting inflammation in the gastrointestinal tract.

Intended Use of Fecal Calprotectin Immunological Test System

A Fecal Calprotectin Immunological Test System is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.

Intended Use

The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn’s disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.

Device Description

This is an in vitro diagnostic assay designed to quantitatively measure fecal calprotectin, a protein marker indicative of intestinal inflammation. Utilizing particle-enhanced turbidimetric immunoassay (PETIA) technology, the assay detects calprotectin levels in stool extracts by measuring light absorbance, which correlates with its concentration.

This single-use device contains an extraction buffer and features a dosing tip to facilitate the collection of an adequate stool sample, which is then mixed with the extraction buffer to create a specimen extract suitable for measurement. These components are essential for the accurate calibration and quality control of the assay, ensuring reliable and consistent results.

• Precision (Reproducibility and Repeatability)
• Accuracy
• Shelf life
• Linearity
• Analytical Specificity/Interference
• Analytical Sensitivity
• Assay Reportable Range
• Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
• Shelf-Life Stability
• Reagent On-Board Stability
• Transport Stability
• Sample Stability
• Product Stability
• Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)
• Assay Cut-Off
• Comparison Studies
• Expected Values/Reference Range

Clinical Testing

    Required for 510k submission