# K031012: Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout Biological Indicator for EO Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 16, 2003 after 199 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steris Verify: named in the summary without a submission number
- (no number) 3M Attest 1292 Rapid Readout Biological Indicator for Steam: named in the summary without a submission number

## Most influential descendants
- K123546: 3M Attest (TM) Auto-Reader (2013), 7 descendants of its own
- K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator (2017), 6 descendants of its own
- K190297: Celerity HP Incubator (2019), 4 descendants of its own
- K213881: Celerity Incubator (2022), 3 descendants of its own
- K223715: Celerity Incubator (2023), 2 descendants of its own

## Indications for use
The 3M Attest 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M Attest 290G Auto-reader. The 3M Attest 1298 Rapid Readout Biological Indicator for EO Test Pack is a routine challenge pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M Attest 290G Auto-reader. The 3M Attest 290G Auto-reader is designed to incubate and automatically read the 3M Attest 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37% for a final negative fluorescence reading at 4 hours.

Source page: https://510kreport.com/device/K031012
Methodology: https://510kreport.com/methodology