| Device |
liquid chemical processing system |
| Regulation Description |
Spore test strip. |
| Definition |
The liquid chemical processing system is intended as a standard method for routine monitoring. |
| Physical State |
The liquid chemical processing monitor consists of a filter paper-based carrier (¼ in x 1⅜ in) inoculated with G. stearothermophilus 7953 spores and packaged in a glassine envelope, a vial containing 5 ml of modified Trypticase Soy Broth with the pH indicator, phenol red media and closed with a screw cap, and a transfer clip. |
| Technical Method |
The device is placed in the system with the load. During the processing cycle, the liquid chemical processing monitor is exposed to the liquid chemical. Some of the spores on the strip will be killed and and some of the spores will be physically washed off the strip. |
| Target Area |
This device is has no patient contact. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | OVY |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6887
|
|---|
| 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 |
