Cleared Traditional

K260822 - VERIFY RESI-TEST SWAB Protein Detection Indicator

K260822 is an FDA 510(k) clearance for VERIFY RESI-TEST SWAB Protein Detection..., manufactured by Steris. The device is a Class 2 General Hospital device with product code SDC cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K260822 · Steris · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
229d
Days
Class 2
Risk

K260822 is an FDA 510(k) clearance for the VERIFY RESI-TEST SWAB Protein Detection Indicator. Classified as Qualitative Cleaning Process Protein Indicator (product code SDC), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on October 28, 2026 after a review of 229 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6930 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260822

510(k) Number K260822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2026
Decision Date October 28, 2026
Days to Decision 229 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 129d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SDC Device Classification - Class 2, Special Controls

Product Code SDC Qualitative Cleaning Process Protein Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6930
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

K260822 · VERIFY RESI-TEST SWAB Protein Detection Indicator
Download PDF FDA Summary Steris