Device type
Qualitative Cleaning Process Protein Indicator
Product code SDC · Class II · 21 CFR 880.6930 · General Hospital
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)s
Oct 28, 2026
K260822
VERIFY RESI-TEST SWAB Protein Detection Indicator
Steris
- SDC
- Class II
Recent recalls
Sep 2, 2026
Z-3031-2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Healthmark Industries Co., Inc.
- SDC
- Class II
- Ongoing
Sep 2, 2026
Z-3032-2026
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Healthmark Industries Co., Inc.
- SDC
- Class II
- Ongoing