# K031114: Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Mar 3, 2004 after 330 days
- Product code: MRB (Indicator, Biological, Liquid Chemical 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1TM, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

Source page: https://510kreport.com/device/K031114
Methodology: https://510kreport.com/methodology