SDC — Qualitative Cleaning Process Protein Indicator Class II
FDA product code SDC covers "Qualitative Cleaning Process Protein Indicator", a Class II medical device regulated under 21 CFR 880.6930. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDC
- Device Class
- Class II
- Regulation Number
- 880.6930
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230085 | steris | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | November 12, 2024 |