Identifiers
- 510(k) Number
- K112018 FDA 510(k)
- FDA Product Code
- FRC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smart Read EZTest Steam is a self-contained biological indicator designed for monitoring biological sterilization processes, specifically steam sterilization. It employs spores of Geobacillus stearothermophilus to detect the effectiveness of sterilization cycles, providing a visual color change upon exposure to sterilization conditions.
This device is intended for single-use in healthcare settings, including general hospital environments, and is supplied as a standalone indicator. It requires no additional processing and is regulated under FDA 510(k) clearance (K112018) as a Class II medical device (FRC product code). Sterility is ensured through the sealed packaging, and it is compatible with standard steam sterilization protocols.
Frequently asked questions
What is the Smart Read EZTest Steam used for in a healthcare setting?
The Smart Read EZTest Steam is a self-contained biological indicator designed specifically for monitoring steam sterilization processes. It uses *Geobacillus stearothermophilus* spores to confirm whether sterilization cycles have effectively killed microbial contaminants, ensuring the safety of sterilized medical instruments and equipment. This makes it ideal for validating sterilization in general hospital environments.
Is the Smart Read EZTest Steam intended for reuse or is it single-use?
The Smart Read EZTest Steam is explicitly designed for single-use only. After exposure to a sterilization cycle, it provides a visual result indicating whether the process was successful, and it should not be reused for subsequent cycles. This ensures accurate and reliable performance for each sterilization validation.
How is sterility maintained for the Smart Read EZTest Steam before use?
Sterility is maintained through the device’s sealed packaging, which protects the biological indicator until it is ready for use. The packaging ensures the spores remain uncontaminated until the indicator is exposed to the sterilization process, at which point it provides a visual confirmation of effectiveness.
What type of regulatory clearance does the Smart Read EZTest Steam hold?
The Smart Read EZTest Steam holds FDA 510(k) clearance under the classification of a Class II medical device (product code: FRC). This clearance was granted through a traditional review process, confirming its substantial equivalence to a predicate device and compliance with U.S. regulatory requirements for biological sterilization indicators.
Does the Smart Read EZTest Steam require any additional processing after use?
No, the Smart Read EZTest Steam is a standalone indicator that requires no additional processing after use. Once exposed to a sterilization cycle, it provides a visual color change to indicate whether the process was successful, allowing for immediate verification without further steps.
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: Smart-Read Products | Mesa Labs, EZTest Biological Indicators | Mesa Labs, Smart-Read EZTest Test Pack - Instrumed Service Co., Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112018 | Class II | Active |
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Manufacturer
- Manufacturer
- Mesa Laboratories, Inc.
Sources (1)
- FDA 510(k) K112018 24 fields · synced Sep 19, 2026