# K181442: VERIFY Assert Self-Contained Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Jun 13, 2018 after 12 days
- Product code: OWP (Biological Sterilization Process Indicator With Recombinant-Dna Plasmid)
- Device class: 2
- Regulation: 21 CFR 880.2805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN110006 (2013). 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)
- K162701: VERIFY Assert Self-Contained Biological Indicator, STERIS Corporation (2017) Summary page 5.

## Indications for use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes. Cycle Type Temperature Time Dynamic Air Removal 270°F (132°C) 4 minutes Dynamic Air Removal 275°F (135°C) 3 minutes Gravity 250°F (121°C) 30 minutes Gravity 270°F (132°C) 15 minutes When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes

Source page: https://510kreport.com/device/K181442
Methodology: https://510kreport.com/methodology