Identifiers
- 510(k) Number
- K232565 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 UriSponge is a Culture Media, Non-Propagating Transport device, designed for the collection, preservation, and transport of urine specimens. It is classified as a Class I medical device under FDA regulations (21 CFR 866.2390) and serves as a sterile, single-use system to maintain specimen integrity during handling and transit to the laboratory.
Supplied as a sterile, single-use device, the UriSponge is intended for clinical microbiology settings. It is packaged individually and requires no special storage conditions beyond standard laboratory practices. Authorised under FDA 510(k) clearance (K232565), IVDD, and IVDR compliance, it adheres to microbiological transport standards without requiring refrigeration. The device is non-magnetic and compatible with MRI environments, though its primary use remains in vitro diagnostic testing for urine cultures.
Frequently asked questions
What is the primary purpose of the UriSponge and where is it typically used?
The UriSponge is designed as a sterile, single-use culture media device for collecting, preserving, and transporting urine specimens. It maintains specimen integrity during handling and transit to the laboratory, making it ideal for clinical microbiology settings where urine cultures are performed.
Is the UriSponge reusable or single-use, and how should it be stored?
The UriSponge is explicitly designed for single-use only. It is packaged individually and requires no special storage conditions beyond standard laboratory practices, ensuring usability in typical clinical environments.
Can the UriSponge be used in an MRI environment, and what regulatory compliance does it hold?
Yes, the UriSponge is non-magnetic and compatible with MRI environments, though its primary use remains in vitro diagnostic testing for urine cultures. It holds FDA 510(k) clearance (K232565), IVDD, and IVDR compliance, adhering to global regulatory standards.
Does the UriSponge require refrigeration during transport, and what are its key specifications?
No, the UriSponge does not require refrigeration for transport, as it is designed to preserve urine specimens without cold storage. It is classified as a Class I medical device under FDA regulations (21 CFR 866.2390) and is categorized under the product code JSM for microbiology applications.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Active |
| EUDAMED | European Union | IVDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K232565 | Class I | Active |
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Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (2)
- FDA 510(k) K232565 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026