Smart-Read EZTest-Steam SCBI and Test Pack
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093794 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 SCBI and Test Pack is a Biological Indicator for Biological Sterilization Process validation, designed to verify the effectiveness of steam sterilization cycles. It contains Geobacillus stearothermophilus spores encapsulated in a porous and nonporous material package, simulating challenging sterilization conditions in medical settings. This device is classified as a Class II medical device under FDA regulations and is intended for use in sterilization processes, including those operating at temperatures of 132°C, 134°C, and 135°C.
The test pack is placed in the sterilizer load in a horizontal position within the most difficult-to-sterilize area to ensure comprehensive validation. It is supplied as a single-use, non-sterile item and requires steam sterilization prior to use. The device is regulated under FDA 510(k) clearance (K093794) and is intended for use in general hospital environments. Storage and handling follow standard biological indicator protocols, with no specific MRI safety considerations.
Frequently asked questions
What is the Smart-Read EZTest-Steam SCBI and Test Pack used for in a clinical setting?
The Smart-Read EZTest-Steam SCBI and Test Pack is a Biological Indicator designed specifically to validate the effectiveness of steam sterilization processes. It contains *Geobacillus stearothermophilus* spores in a package that mimics challenging sterilization conditions, ensuring that sterilizers operating at temperatures like 132°C, 134°C, and 135°C are functioning correctly. It is placed in the most difficult-to-sterilize area of the load to confirm comprehensive validation.
Is the Smart-Read EZTest-Steam SCBI and Test Pack single-use or reusable?
The Smart-Read EZTest-Steam SCBI and Test Pack is explicitly designed for single-use only. It is supplied in a non-sterile state and requires steam sterilization before use, meaning each pack is intended for one validation cycle only. Reuse is not recommended or supported by the manufacturer.
How should the Smart-Read EZTest-Steam SCBI and Test Pack be stored and handled?
The device follows standard biological indicator protocols for storage and handling, though no specific storage conditions are detailed beyond typical medical device guidelines. Since it is non-sterile as supplied, it must be steam-sterilized prior to use in validation cycles. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following general best practices for biological indicators to maintain integrity until use.
What regulatory pathway does the Smart-Read EZTest-Steam SCBI and Test Pack follow?
The Smart-Read EZTest-Steam SCBI and Test Pack is regulated under the FDA 510(k) clearance pathway, with the clearance number K093794. It is classified as a Class II medical device and is intended for use in general hospital environments. The device was submitted to the FDA’s General Hospital (HO) Advisory Committee and received a Substantially Equivalent (SESE) decision, confirming its compliance with existing sterilization validation standards.
How is the Smart-Read EZTest-Steam SCBI and Test Pack positioned during sterilization?
The test pack must be placed in the sterilizer load in a horizontal position, specifically within the area identified as the most difficult to sterilize. This ensures the biological indicator accurately reflects the sterilization process’s effectiveness across the entire load, particularly for challenging conditions like those encountered in medical settings.
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 EZTEST-STEAM SCBI AND TEST PACK (K093794) — FDA 510 (k ..., Smart-Read Products | 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 | K093794 | Class II | Active |
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Manufacturer
- Manufacturer
- Sgm Biotech, Inc.
Sources (1)
- FDA 510(k) K093794 24 fields · synced Sep 20, 2026