Cleared Traditional

K061597 - EPOC BLOOD ANALYSIS SYSTEM

K061597 is the FDA 510(k) clearance for EPOC BLOOD ANALYSIS SYSTEM by Epocal, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K061597 · Epocal, Inc. · Chemistry device
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Sep 2006
Decision
111d
Days
Class 2
Risk

K061597 is an FDA 510(k) clearance for the EPOC BLOOD ANALYSIS SYSTEM. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on September 27, 2006 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K061597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date September 27, 2006
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 112
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K061597.
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · Medica Corp. · Apr 2010
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861 · Ortho-Clinical Diagnostics, Inc. · Sep 2009
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc. · Jun 2008
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · Teco Diagnostics · Dec 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · Roche Diagnostics Corp. · Dec 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · Pointe Scientific, Inc., · Oct 2005