Copan FecalSwab Collection, Transport and Preservation System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K220052 FDA 510(k)
- FDA Product Code
- JSM FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2390 FDA 510(k)
- Regulation Number
- 866.2390 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Copan FecalSwab Collection, Transport and Preservation System is a non-propagating transport medium designed for the collection, transport, and preservation of fecal specimens. It is intended for microbiological testing to detect enteric bacteria and pathogens, ensuring sample viability during transit to the laboratory. The system combines a flocked swab with a liquid medium to maintain bacterial integrity, facilitating accurate diagnostic analysis.
This system is supplied as a single-use device, intended for use in clinical microbiology laboratories. It is not sterile but is designed to preserve sample viability during transport, typically within 48 hours of collection. The system is classified under FDA regulation 866.2390 and has received FDA 510(k) clearance and IVDD authorization. The device is packaged for individual use and must be stored according to manufacturer instructions to maintain efficacy.
Frequently asked questions
What is the Copan FecalSwab Collection, Transport and Preservation System used for?
This system is designed for collecting, transporting, and preserving fecal specimens to ensure bacterial viability during transit to the laboratory. It combines a flocked swab with a liquid medium to maintain the integrity of enteric bacteria and pathogens, enabling accurate microbiological testing.
Is the Copan FecalSwab system sterile?
No, the Copan FecalSwab Collection, Transport and Preservation System is not sterile. It is specifically designed as a non-propagating transport medium to preserve sample viability during transport, rather than to provide a sterile environment.
How should the Copan FecalSwab system be stored?
The system must be stored according to the manufacturer’s instructions to maintain its efficacy. Proper storage conditions ensure the liquid medium remains effective in preserving bacterial integrity during transport.
Is the Copan FecalSwab system intended for single-use or reuse?
The Copan FecalSwab Collection, Transport and Preservation System is supplied as a single-use device. This design ensures patient safety and sample integrity, as reuse could compromise sterility and accuracy.
What is the maximum time frame for transporting a fecal sample using this system?
The system is designed to maintain sample viability for up to 48 hours during transport, allowing sufficient time for specimens to reach the laboratory while preserving bacterial integrity for accurate diagnostic testing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FecalSwab® System for Enteric Bacteria - COPAN, FecalSwab™ - Copan, FecalSwab® FAQ - COPAN
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K220052 | Class I | Active |
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Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (2)
- FDA 510(k) K220052 24 fields · synced Oct 1, 2026
- EUDAMED 1 fields · synced May 29, 2026