# K162701: VERIFY Assert Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 24, 2017 after 177 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: 1 generation back to DEN110006 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110006: Verify Cronos Self-Contained Biological Indicator, STERIS Corporation (2013). Our reading of the summary gave K102469, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110006, Verify Cronos Self-Contained Biological Indicator (STERIS Corporation), granted Jul 12, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 5.

## Most influential descendants
- K181442: VERIFY Assert Self-Contained Biological Indicator (2018), 0 descendants of its own

## 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/K162701
Methodology: https://510kreport.com/methodology