PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
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 |
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.
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
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