Cleared Traditional

K152327 - EasyLyte Na/K/Cl/Ca Analyzer (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152327 · Medica Corporation · Chemistry device
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Dec 2016
Decision
471d
Days
Class 2
Risk

K152327 is an FDA 510(k) clearance for the EasyLyte Na/K/Cl/Ca Analyzer. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on December 1, 2016 after a review of 471 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Medica Corporation devices

Submission Details

510(k) Number K152327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2015
Decision Date December 01, 2016
Days to Decision 471 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
383d slower than avg
Panel avg: 88d · This submission: 471d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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.