Cleared Traditional

K092346 - SERIM D-CIDE GTA 1.5% TEST STRIP

K092346 is the FDA 510(k) clearance for SERIM D-CIDE GTA 1.5% TEST STRIP by Serim Research Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K092346 · Serim Research Corp. · General Hospital
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Jan 2010
Decision
156d
Days
Class 2
Risk

K092346 is an FDA 510(k) clearance for the SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on January 7, 2010 after a review of 156 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.

View all Serim Research Corp. devices

Submission Details

510(k) Number K092346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date January 07, 2010
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
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