# K200092: 3MTM AttestTM Mini Auto-reader 490M

- Pathway: 510(k) (Traditional)
- Applicant: 3M
- Decided: Apr 15, 2020 after 90 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926364 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173437: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H, 3M Company (2018) Summary page 5.

## Indications for use
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, at 60°C for a final fluorescent result at 24 minutes. The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for these BIs is the addition of the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs: Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C). An optional visual pH color change result is observed in 24 hours. Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C). An optional visual pH color change result is observed in 48 hours. Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.

Source page: https://510kreport.com/device/K200092
Methodology: https://510kreport.com/methodology