# DEN230085: VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

- Pathway: De Novo (Direct)
- Applicant: Steris
- Decided: Nov 12, 2024 after 330 days
- Product code: SDC (Qualitative Cleaning Process Protein Indicator)
- Device class: 2
- Regulation: 21 CFR 880.6930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The VERIFYTM RESI-TESTTM SLIDE-THRU Cleaning Process Protein (CPP) Indicator is a qualitative protein detection test used on a medical device brushable lumen to detect the presence of residual protein in the extracted soils from the brush after cleaning and prior to high level disinfection or sterilization. This is assessed through any solution color change from brown/tan to green/gray/blue. The indicator may become more blue when exposed to higher levels of residual protein soils in the extract. Use only with VERIFY RESI-TEST SLIDE-THRU Brush (sold separately) for the lumen size range, as shown below: - Large brush: 2.8-5.0 mm / 290 cm length - Medium brush: 1.5-2.6 mm / 220 cm length - Small brush: 1.0-1.2mm / 150 cm length.

Source page: https://510kreport.com/device/DEN230085
Methodology: https://510kreport.com/methodology