Medical Wire & Equipment Company (Bath), Ltd. · Class I · Cleared Nov 26, 2025
| K-number | K242976 |
| Device name | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device |
| Applicant | Medical Wire & Equipment Company (Bath), Ltd. |
| Product code | JSM |
| Device class | Class I |
| Decision date | Nov 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is a sterile collection kit containing a plastic tube filled with 2 ml of Liquid Cary Blair transport medium and a foam-tipped specimen collection swab. It is intended to preserve the viability and infectivity of fecal specimens during collection and transport to the testing laboratory, supporting the detection of enteric pathogenic bacteria.
The device uses a conical tube with screw cap containing liquid Cary Blair medium (inorganic phosphate buffer, calcium chloride, sodium chloride, and sodium thioglycollate). Key differences from the predicate include a foam-tipped swab rather than flocked nylon, a longer shelf-life of 24 months versus 15 months, and a different medium formulation without agar or L-cysteine. Both devices support identical specimen types and microorganism recovery.
Performance testing followed CLSI M40-A2 (Quality Control of Microbiological Transport Systems; Approved Standard) using recognized strains of fecal bacteria for roll-plate and swab elution studies at refrigeration and room temperature conditions.
View the full FDA submission: accessdata.fda.gov