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U.S. Department of Health and Human Services

Product Classification
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Device biological sterilization process indicator with recombinant-dna plasmid
Definition A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
Physical State Bacterial spores containing recombinant-DNA plasmids are provided in an ampoule with a separate, contained compartment of appropriate growth media. The ampoule design should segregate the spores from the growth media until incubation and facilitate contained mixing, when required, of the spores and growth media without exposing any spores to the external environment.
Technical Method The device consists of known number of genetically-modified bacterial spores, with known resistance to the intended sterilization process, containing deliberately introduced recombinant-DNA plasmids. The plasmids provide a new indicator signal mechanism to determine the presence of viable bacteria in the indicator signaling a failure in the sterilization process. Plasmid safety is evaluated by an Environmental Assessment in addition to performance testing.
Target Area The device is intended to be included with sterilization loads, within sterilization wraps, containers, pouches, trays and cassettes during sterilization cycles for which the use of this device has been validated.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOWP
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 880.2805
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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