# K200272: Terragene Chemdye

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Jun 30, 2020 after 147 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
Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132°C for 4 minutes and 134ºC for 3.5 minutes in dynamic-air-removal steam sterilizers.

Source page: https://510kreport.com/device/K200272
Methodology: https://510kreport.com/methodology