3M Attest Rapid Readout Biological Indicator 1295
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K210277 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 3M Attest Rapid Readout Biological Indicator 1295 is a biological indicator designed for monitoring sterilization processes, specifically for vaporized hydrogen peroxide (VH₂O₂) systems. Classified as an indicator for biological sterilization processes, it provides a biological challenge to validate the effectiveness of sterilization cycles, ensuring microbial inactivation.
This single-use device is intended for use in general hospital settings and requires incubation followed by automated reading in compatible readers such as the 3M Attest Auto-reader 490H or 490 (software version 4.2.7 or higher). Supplied in sterile packaging (24 indicators per bag, 4 bags per case, 120 per case), it is regulated under FDA 510(k) clearance (K210277) and falls under device class II. No MRI safety information is specified.
Frequently asked questions
What is the 3M Attest Rapid Readout Biological Indicator 1295 used for?
The 3M Attest Rapid Readout Biological Indicator 1295 is designed to validate the effectiveness of sterilization processes using vaporized hydrogen peroxide (VH₂O₂) systems. It provides a biological challenge to ensure microbial inactivation during sterilization cycles, which is critical for confirming the sterility of medical devices and equipment in general hospital settings.
How is the 3M Attest 1295 supplied, and what does the packaging include?
The 3M Attest Rapid Readout Biological Indicator 1295 is supplied in sterile packaging. Each case contains 120 indicators, organized as 24 indicators per bag and 4 bags per case. This ensures sterility and readiness for immediate use in monitoring sterilization processes.
Is the 3M Attest 1295 single-use or reusable?
The 3M Attest Rapid Readout Biological Indicator 1295 is explicitly designed for single-use only. After use, it should be discarded to avoid contamination and ensure accurate validation of sterilization cycles.
What equipment is required to read the results of the 3M Attest 1295?
The 3M Attest Rapid Readout Biological Indicator 1295 requires incubation followed by automated reading using compatible readers such as the 3M Attest Auto-reader 490H or 490. These readers must be running software version 4.2.7 or higher to ensure accurate and reliable result interpretation.
How should the 3M Attest 1295 be stored?
While the device data does not specify storage conditions explicitly, biological indicators like the 3M Attest 1295 should generally be stored in a clean, dry environment protected from extreme temperatures and direct sunlight. Ensure the sterile packaging remains intact until use to maintain sterility and functionality.
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: 3M ATTEST 1295 MANUAL Pdf Download | ManualsLib, 3M Attest 1295 Rapid Readout Biological lndicator, 3M Biological Indicators for Health Care | 3M United States, 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide (H₂O₂) Biological ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210277 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K210277 24 fields · synced Oct 1, 2026