Inova Diagnostics, San Diego, a manufacturer of clinical laboratory reagents and diagnostic systems for autoimmune disease, has received FDA premarket notification (510(k)) clearance for a fecal extraction device to be used in conjunction with the company’s Quanta Flash Calprotectin assay.

The Quanta Flash Calprotectin test is a chemiluminescent immunoassay for the detection of fecal calprotectin in human stool samples. High concentrations of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, may assist in the diagnosis and management of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, and helps differentiate IBD from irritable bowel syndrome (IBS).

The availability of Inova’s proprietary fecal extraction device will simplify the extraction procedure and improve laboratory productivity. The first such device to receive FDA clearance, Inova’s fecal extraction device is an accurate and easy-to-use device that provides significant workflow improvement to the laboratory compared with manual weighing of samples. The device correlates well to the manual weighing method, allows extracted sample to be stored at room temperature for up to 72 hours, and can be placed directly on Inova’s Bio-Flash system for convenient sample processing.

The Bio-Flash system is a random-access chemiluminescent analyzer for the autoimmune laboratory that delivers results in as little as 30 minutes. The instrument offers a wide analytical measuring range and precise quantification of test results, and represents a step forward for the handling of routine, specialized, and stat immunology tests. Bio-Flash is a registered trademark of Biokit SA, Barcelona.

For further information, visit Inova Diagnostics.