Cleared Traditional

K113726 - EPOC CHLORIDE TEST AND EPOC CREATININE ...

K113726 is the FDA 510(k) clearance for EPOC CHLORIDE TEST AND EPOC CREATININE ... by Epocal, Inc.. It is a Class 2 Chemistry device (product code CGL) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K113726 · Epocal, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
291d
Days
Class 2
Risk

K113726 is an FDA 510(k) clearance for the EPOC CHLORIDE TEST AND EPOC CREATININE TEST. Classified as Electrode, Ion Based, Enzymatic, Creatinine (product code CGL), Class II - Special Controls.

Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on October 5, 2012 after a review of 291 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Epocal, Inc. devices

Submission Details

510(k) Number K113726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date October 05, 2012
Days to Decision 291 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 88d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGL Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGL Electrode, Ion Based, Enzymatic, Creatinine

Devices cleared under the same product code (CGL) and FDA review panel - the closest regulatory comparables to K113726.
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NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
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K991727 · Nova Biomedical Corp. · Jul 1999