FDA Clears Copan Diagnostics’ Urine Collection Device

Copan Diagnostics’ urine collection and transport device, which uses a new formulation of advanced preservatives to ensure specimen stability for culture, has received U.S. Food and Drug Administration (FDA) clearance. The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport, according to the company.

“Copan is dedicated to advancing laboratory practices through groundbreaking innovation,” Copan Diagnostics CEO Fabrizio Mazzochi said. “UriSponge provides a reliable and efficient solution that supports laboratory needs while offering healthcare providers a safe, streamlined process.”

Urine samples constitute nearly 70% of specimens processed annually in clinical laboratories. Urine specimens are collected and processed to cultivate uropathogenic bacteria and yeasts. UriSponge enables urine transfer from sterile container to tube using a quick dip-and-close method reducing steps and improving workflow.

The system features a screw-cap tube with a plastic applicator and sponges loaded with preservatives. Upon contact with urine, these preservatives maintain sample stability during transport, providing dependable results and minimizing the risk of contamination or degradation. The design ensures accurate sample preservation without requiring precise fill lines or additional mixing, reducing complexity and the use of extra consumables.

UriSponge is designed with advanced preservatives to ensure specimen integrity, offering an alternative to traditional methods that require stringent handling protocols.

UriSponge integrates seamlessly with laboratory automation such as Copan’s WASP Walk-Away Specimen Processor, which automates essential microbiology specimen processing tasks, including planting and streaking. UriSponge and Copan’s full laboratory automation solution offer a streamlined approach to specimen handling from collection through analysis, aimed at enhancing laboratory productivity and consistency.

Murrieta, Calif.-based Copan Diagnostics is part of Copan Group, a global manufacturer of collection and transport systems. Through its collaborative approach, Copan has developed technologies such as FLOQSwabs, ESwab, UTM Universal Transport Medium, and Full Laboratory Automation and artificial intelligence.