# K232103: Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Apr 5, 2024 after 266 days
- Product code: QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator)
- 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® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® NX Sterilization System (Standard and Advanced cycles). • Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles). • Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles). • Sterrad® l00NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles). The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met. Terragene® Chemdye® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® NX Sterilization System (Standard and Advanced cycles). • Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles). • Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles). • Sterrad® l00NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles). • Sterizone® VP4 Sterilizer (Cycle 1). The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® NX Sterilization System (Standard and Advance cycles). • Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles). • Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles). • Sterrad® l00NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible cycles). • Sterizone® VP4 Sterilizer (Cycle 1). The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K232103
Methodology: https://510kreport.com/methodology