# K052128: 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-Reader

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Aug 16, 2005 after 11 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: 1 generation back to K004009 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004009: 3M Attest 290 Auto-Reader, 3M Company (2002) Summary page 2.
- K031012: Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout Biological Indicator for EO Test Pack, 3M Company (2003) Summary page 2.

## Indications for use
The 3M Attest 293 Auto-reader is designed to incubate and automatically read the 3M Attest 1291 and/or 3M Attest 1292 Rapid Readout Biological Indicators for Steam, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292. The 3M Attest 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative, visual pH color change of the growth media at 24 hours for Attest 1291 and 48 hours for Attest 1292. The 3M Attest 293G Auto-reader is designed to incubate and automatically read the 3M Attest 1294 Rapid Readout Biological Indicators (RRBI) for EO, at 37°C for a final negative fluorescence reading at 4 hours.

Source page: https://510kreport.com/device/K052128
Methodology: https://510kreport.com/methodology