MTC · Indicator, Chemical, Enzymatic, Sterilization Process
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | MTC |
|---|---|
| Device Name | Indicator, Chemical, Enzymatic, Sterilization Process |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210481 | Instant 20s Indicator | True Indicating, LLC | Dec 14, 2021 | SESE |
| K962649 | SPORTROL RAPID STERILITY INDICATOR | North American Science Assoc., Inc. | Sep 26, 1997 | SESE |
Top Applicants
- North American Science Assoc., Inc. — 1 clearance
- True Indicating, LLC — 1 clearance
