SDC — Qualitative Cleaning Process Protein Indicator Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
DEN230085sterisVERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) IndicatorNovember 12, 2024