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U.S. Department of Health and Human Services

Product Classification

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Device liquid chemical processing system
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 CodeOVY
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible