# K050664: Spor-Test PA Biological Indicator Kit

- Pathway: 510(k) (Special)
- Applicant: Getinge USA, Inc.
- Decided: Apr 7, 2005 after 23 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
Longest line of descent: 3 generations back to K792649 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020205: Castle Peracetic Acid Biological Indicator Kit, Getinge/Castle, Inc. (2002) Summary page 1.

## Indications for use
The SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System I liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. SPOR-TEST PA Biological Indicators are qualified using Getinge Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

Source page: https://510kreport.com/device/K050664
Methodology: https://510kreport.com/methodology