SDC · Qualitative Cleaning Process Protein Indicator

General Hospital · 21 CFR 880.6930 · Class 2

Overview

Identification

The VERIFY™ RESI-TEST™ SLIDE-THRU Cleaning Process Protein (CPP) Indicator is a qualitative protein detection test used on a medical device brushable lumen to detect the presence of residual protein in the extracted soils from the brush after cleaning and prior to high level disinfection or sterilization. The device consists of a solution that changes color (from brown/tan to green/gray/blue) in the presence of protein, a protein standard, and reaction vials, designed for use with specific endoscope brushes.

Classification Rationale

Class II (special controls). The device is a qualitative cleaning process protein indicator, which is subject to general controls and the identified special controls to mitigate risks such as adverse tissue reaction, inaccurate interpretation of test results, and damage to cleaned medical devices.

Special Controls

In combination with the general controls of the FD&C Act, the qualitative cleaning process protein indicator device is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) For cleaning process protein indicator devices with mechanical components and/or accessories, functional testing of these components and accessories must demonstrate maintenance of functional integrity for the intended use; (ii) Compatibility with cleaned medical devices; (iii) Simulated use test must evaluate the cleaning process protein indicator device performance on a cleaned medical device under worst-case conditions. If simulated use testing cannot represent the worst-case clinical use condition, then in-use test must demonstrate the device performs as intended per indications for use with clinically used medical devices, under worst-case conditions; and (iv) Stability test must demonstrate the device performs in accordance with the device indications for use and instruction for use for the claimed shelf life under the labeled storage conditions. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) The labeling must include: (i) A statement specifying the types of health care users that can use the cleaning process protein indicator device; (ii) Instructions for observation and interpretation of qualitative test results, including any limitations; (iii) Instructions that the use of the cleaning process protein indicator device should not alter implementation of the cleaned medical device manufacturer’s validated reprocessing instructions; (iv) Stability of test results; (v) Cleaned medical device compatibility and incompatibility information; (vi) Instructions for personal protective equipment to be used with the device; and (vii) A shelf-life.

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