Cleared Traditional

K100829 - EASYRA SODIUM ASSAY

K100829 is the FDA 510(k) clearance for EASYRA SODIUM ASSAY by Medica Corp.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K100829 · Medica Corp. · Chemistry device
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Jan 2011
Decision
296d
Days
Class 2
Risk

K100829 is an FDA 510(k) clearance for the EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CA.... 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 January 14, 2011 after a review of 296 days - an extended review cycle.

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 Medica Corp. devices

Submission Details

510(k) Number K100829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2010
Decision Date January 14, 2011
Days to Decision 296 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 88d · This submission: 296d
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 79
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K100829.
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VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc. · Jun 2008
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · Roche Diagnostics Corp. · Dec 2005