FDA 510(k) Clearance for Transport System for Stool Culture
Medical Wire & Equipment (MWE) is pleased to confirm that the FECAL TRANSWAB® with Liquid Cary Blair Medium Specimen Collection and Transport System is FDA 510(k) cleared for preserving the viability fecal specimens during transport to the laboratory for microbiological testing.
Evidence-Based Performance
The FDA 510(k) clearance follows analytical validation and a 10-organism test panel, representing clinically relevant targets encountered in gastrointestinal infection workflows.
Performance testing demonstrated:
- Reliable recovery of aerobic, anaerobic and fastidious organisms
- High performance in Campylobacter transport
- Clostridium recovery in 24 hours
- All other organisms recovered at 48 hours
Designed for Laboratory Workflows
The cleared system can be used to collect stool specimens directly from a patient as a rectal swab or to transfer material from an existing stool sample. Specimens are processed according to standard clinical microbiology procedures, requiring no changes in laboratory workflow.
Transport and Storage Efficiency
A key advantage of FECAL TRANSWAB® with Liquid Cary Blair Medium is its ability to maintain performance at room temperature, helping to reduce reliance on refrigerated logistics. When combined with a 24-month shelf life, this supports practical inventory management for hospitals, public health networks and reference laboratories.
A Global Solution, Now Cleared in the U.S.
Already established across Europe, Asia, Australasia and major global health institutions, FECAL TRANSWAB® with Liquid Cary Blair Medium now joins MWE’s growing portfolio of FDA-cleared systems designed to support routine diagnostics and infectious disease surveillance.
MWE will work with U.S. healthcare providers, distribution partners and public laboratories to support implementation and availability nationwide.
Get in touch to be a part of this exciting expansion.
