PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR

K960089 · Cottrell, Ltd. · JOJ · Apr 4, 1996 · General Hospital

Device Facts

• Record ID: K960089
• Device Name: PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
• Applicant: Cottrell, Ltd.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.

Device Story

Chemical indicator strip; monitors glutaraldehyde concentration in activated solutions (2-3.5%). User dips strip into solution; indicator pad changes color from yellow to purple if glutaraldehyde concentration is ≥ 1.75%. Used by healthcare personnel in clinical settings to verify disinfectant efficacy. Provides visual pass/fail result to ensure solution meets minimum effective concentration requirements for sterilization/disinfection processes.

Clinical Evidence

Bench testing only. Evaluated permeability of moisture-proof shipping containers via weight-gain analysis (silica gel bags) in controlled environment (65% humidity, 40°C). No weight gain observed, confirming packaging integrity.

Technological Characteristics

Chemical indicator strip; colorimetric reaction (yellow to purple). Identical to Albert Browne Ltd. GA Concentration Monitor. Packaged in moisture-proof containers.

Indications for Use

Indicated for monitoring the concentration of activated glutaraldehyde solutions (2-3.5%) to ensure a minimum effective concentration of at least 1.5%.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Albert Browne Ltd., GA Glutaraldehyde Concentration Monitor
• Pymah Corporation Cold Sterilog Glutaraldehyde Monitor

Submission Summary (Full Text)

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APR - 4 1996
K960089

# 510(k) SUMMARY

## ProChek® G Glutaraldehyde Concentration Level Indicator

### January 4, 1996

## 1. SUBMITTER NAME AND ADDRESS

### 1.1 Submitter

Cottrell, Ltd.
7399 South Tucson Way
Englewood, CO 80112
Telephone # (800) THE-EDGE
Telefax # [phone]
John Scoville, Director of Regulatory Affairs and Quality Assurance

## 2. DEVICE NAME

Proprietary Name: ProChek® G Glutaraldehyde Concentration Level Indicator
Common/Usual Name: Glutaraldehyde Concentration Indicator
Classification Name: Sterilization Process Indicator; Physical/Chemical Process Indicator

## 3. PREDICATE DEVICES

Albert Browne Ltd., GA Glutaraldehyde Concentration Monitor
Pymah Corporation Cold Sterilog Glutaraldehyde Monitor

## 4. INTENDED USE

The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.

## 5. DEVICE DESCRIPTION

The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor

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solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.

## 6. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Cottrell, Ltd. ProChek® G Glutaraldehyde Concentration Level Indicator are identical to those of the Albert Browne Ltd. GA Concentration Monitor. The proposed device is the same indicator, purchased in bulk from the manufacturer, and packaged and labeled by Cottrell, Ltd.

## 7. TESTING

This testing was performed to evaluate the permeability of the moisture proof containers used for shipping the ProChek® G Glutaraldehyde Concentration Level Indicator from Albert Browne Ltd. to Cottrell, Ltd. for packaging and labeling.

To test the permeability of the shipping containers, containers were filled with silica gel bags and sealed. The weight of each container was recorded immediately after sealing. After twelve hours, in a controlled environment of 65% humidity at 40°C, the containers were weighed and compared with the weights obtained at the time of sealing. None of the experimental containers used for shipping gained weight.

Testing demonstrates that the packaging modification does not impact the safety or effectiveness of the device.

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