Cleared Traditional

STERICHEK PERACETIC ACID REAGENT STRIPS (K980164) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980164 · Environmental Test Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
90d
Days
Class 2
Risk

K980164 is an FDA 510(k) clearance for the STERICHEK PERACETIC ACID REAGENT STRIPS. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 16, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Environmental Test Systems, Inc. devices

Submission Details

510(k) Number K980164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date April 16, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

All 12
Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K980164.
Chlorine Sentinel II
K243898 · Nelson Environmental Technologies, Inc. · Apr 2025
E-Z Chek Chlorine Residual Test Strips (K100-0101B)
K222167 · Reprocessing Products Corporation (Rpc) · Oct 2022
Nelson Sentinel Series Basic Chlorine Sentinel
K193169 · Nelson Environmental Technologies, Inc. · Oct 2020