FDA Product Code SDC: Qualitative Cleaning Process Protein Indicator
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.
Leading manufacturers include Steris.
FDA 510(k) Cleared Qualitative Cleaning Process Protein Indicator Devices (Product Code SDC)
About Product Code SDC - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SDC since 2024, with 0 receiving FDA clearance (average review time: 330 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →