Cleared Traditional

K102296 - VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)

K102296 is an FDA 510(k) clearance for VERIFY CHEMICAL MONITORING STRIP FOR RE..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K102296 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
180d
Days
Class 2
Risk

K102296 is an FDA 510(k) clearance for the VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP V.... Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 9, 2011 after a review of 180 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 - K102296

510(k) Number K102296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2010
Decision Date February 09, 2011
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 259
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K102296.
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DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
K102761 · Dana Products, Inc. · Dec 2010
K102296 · VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
Download PDF FDA Summary STERIS Corporation