Attest Brand Rapid Readout Biological Indicator
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K900771 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 Attest Rapid Readout Biological Indicator 1292 is a Biological Sterilization Process Indicator designed to validate steam sterilization cycles. It detects the presence of Geobacillus stearothermophilus organisms, ensuring the effectiveness of sterilization by indicating process failure through a colorimetric reaction from purple to yellow within three hours.
This single-use, non-sterile device is intended for use in general hospital settings to monitor both gravity displacement (250°F/121°C) and vacuum-assisted (270°F/132°C) steam sterilization cycles. Supplied as a reusable packaging system, it requires no special storage conditions and is regulated under FDA 510(k) clearance (K900771) for Class II medical devices. The indicator’s fluorescent endpoint confirms sterilization success or failure without additional instrumentation.
Frequently asked questions
What types of sterilization cycles can this biological indicator validate, and how quickly will I know the results?
The Attest Rapid Readout Biological Indicator is designed to validate both gravity displacement (250°F/121°C) and vacuum-assisted (270°F/132°C) steam sterilization cycles. Results are available within three hours, with a colorimetric change from purple to yellow indicating process failure. If the indicator remains purple, sterilization success is confirmed without needing additional equipment.
Is this device single-use or reusable, and what are the storage requirements?
The Attest Rapid Readout Biological Indicator is a single-use device, meaning each indicator is intended for one sterilization cycle only. It is supplied in a reusable packaging system and does not require special storage conditions, such as refrigeration or humidity control, making it convenient for general hospital use.
How do I know if the sterilization process was successful, and what does the color change mean?
Sterilization success is confirmed if the indicator remains purple after the cycle, indicating no *Geobacillus stearothermophilus* organisms survived. If the color shifts to yellow, it signals process failure—meaning the sterilization cycle did not achieve the required lethality. No extra tools are needed to interpret the result.
What regulatory pathway was followed for this device, and is it approved for use in general hospitals?
The Attest Rapid Readout Biological Indicator was cleared through the FDA 510(k) pathway under the classification of Class II medical devices, with a clearance number of K900771. It is explicitly intended for use in general hospital settings, as indicated by its advisory committee designation (HO) and regulatory filings.
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™ Rapid Steam Biological Indicator, 1292, 3M Attest 1292 Rapid Readout Biological Indicator, 3M™ Attest™ Rapid Steam Biological Indicator, 1292E
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900771 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K900771 24 fields · synced Sep 19, 2026