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.
| Device Type ID | 2733 |
| Device Name | Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| 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 C |
| 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 Mechan |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.2805 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OWP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2733 |
| Device | Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| Product Code | OWP |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 880.2805 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Device Disinfection Or Sterilization Issue | 1 |
Device Reprocessing Problem | 1 |
| Total Device Problems | 2 |