| Device |
qualitative cleaning process protein indicator |
| Definition |
A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract. |
| Physical State |
Protein detection indicator designed for use in the reprocessing of medical devices in health care settings. The device may include additional components for sampling. The device may include a color chart for qualitative indication of the residual soil protein. |
| Technical Method |
A physical or chemical change occurs at the presence of the residual protein at levels relevant to cleaning validation endpoints. |
| Target Area |
The device is intended to be used on a cleaned medical device prior to high level disinfection or sterilization of the cleaned medical device. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SDC |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6930
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
