3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader…
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K173437 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 device is a biological indicator system used to monitor the efficacy of steam sterilization processes. It consists of the 3M Attest Super Rapid Readout Biological Indicator 1492V, which is incubated and read by the 3M Attest Auto-reader 490 or 490H to provide a fluorescent result after 24 minutes, indicating whether sterilization conditions have been met.
The system is intended for use in healthcare settings to monitor 270°F (132°C) to 275°F (135°C) dynamic-air-removal steam sterilization cycles. It is supplied as a non-sterile, single-use biological indicator paired with a reusable auto-reader device. The product has received FDA 510(k) clearance under K173437 and is classified as a Class II medical device with product code FRC.
Frequently asked questions
What is the 3M Attest Super Rapid Readout Biological Indicator system used for?
The system is used to monitor the efficacy of steam sterilization processes by detecting whether conditions have been sufficient to kill resistant microbial spores, providing a fluorescent readout after incubation to confirm sterilization success.
How is the 3M Attest Super Rapid Readout Biological Indicator supplied and is it reusable?
The biological indicator (1492V) is supplied as a non-sterile, single-use item designed for one-time use per cycle, while the auto-reader units (490 and 490H) are reusable devices that incubate and read the indicator to produce a fluorescent result.
What steam sterilization cycles is the 3M Attest system intended to monitor?
The system is intended for use in monitoring 270°F (132°C) to 275°F (135°C) dynamic-air-removal steam sterilization cycles commonly used in healthcare settings to ensure proper sterilization of instruments and equipment.
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: PDF 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Super Rapid Steam Biological Indicator, 1492, 3M™ Attest™ Auto-reader, 490 - solventum.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173437 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K173437 24 fields · synced Oct 6, 2026