Qualitative Cleaning Process Protein Indicator
A qualitative cleaning process protein indicator is a hospital-use device intended for use by healthcare providers on a cleaned medical device as an interim step prior to high-level disinfection or sterilization, providing a qualitative indication of the presence of residual soil protein in a sample extract to verify cleaning adequacy. It is classified as FDA Class II (510(k) required) under regulation 880.6930 in the General Hospital specialty, with product code SDC. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDC
- Device Class
- FDA class 2
- Regulation Number
- 880.6930
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Nov 12, 2024 | Unknown | Steris |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.