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

• K Number: K232103
• Device Name: Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
• Manufacturer: Terragene SA
• Date Cleared: 2024-04-05 ( 266 days)
• Product Code: QKM , JOJ , OKM
• Regulation Number: 880.2800
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended 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® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast 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® 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® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast 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® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast 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.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the ground truth used for any of the Terragene products (Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)).

The document is an FDA 510(k) clearance letter, which confirms that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices for their stated indications. It outlines regulatory requirements and general information about FDA processes but does not detail the specific studies, testing methodologies, or results that demonstrate the devices meet performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).