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.