# K024079: Alibi Biological Indicator, Model WS

- Pathway: 510(k) (Abbreviated)
- Applicant: Arden Laboratories, Incorporated
- Decided: Feb 27, 2003 after 79 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Raven Bacterial Spore Strip: named in the summary without a submission number

## Indications for use
The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.

Source page: https://510kreport.com/device/K024079
Methodology: https://510kreport.com/methodology