# Qualitative Cleaning Process Protein Indicator
> **Product code: SDC** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6930
## Classification
- **FDA Product Code:** SDC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.6930
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SDC)
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