# K983451: Challenge Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: North American Science Assoc., Inc.
- Decided: Apr 23, 1999 after 205 days
- Product code: JOJ (Indicator, Physical/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
RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.

Source page: https://510kreport.com/device/K983451
Methodology: https://510kreport.com/methodology