K-numberK242976
Device nameMedical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
ApplicantMedical Wire & Equipment Company (Bath), Ltd.
Product codeJSM
Device classClass I
Decision dateNov 26, 2025
DecisionSubstantially Equivalent
Regulation
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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