Cleared Special

K100673 - EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

K100673 is an FDA 510(k) clearance for EASYLYTE NA/K/CL/LI ANALYZER, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code JGS cleared through the Special 510(k) pathway after a 28-day FDA review.

K100673 · Medica Corp. · Chemistry device
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Apr 2010
Decision
28d
Days
Class 2
Risk

K100673 is an FDA 510(k) clearance for the EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 6, 2010 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100673

510(k) Number K100673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2010
Decision Date April 06, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

JGS Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K100673.
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
K102647 · Elitechgroup Vital Scientific BV · Mar 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829 · Medica Corp. · Jan 2011
PROLYTE ELECTROLYTE ANALYZER
K102959 · Diamond Diagnostics, Inc. · Jan 2011
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861 · Ortho-Clinical Diagnostics, Inc. · Sep 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · Diamond Diagnostics, Inc. · Feb 2009
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc. · Jun 2008
K100673 · EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
Download PDF Medica Corp.