Cleared Traditional

EASYQC - CHEMISTRY WITH ELECTROLYTES (K080404) - FDA 510(k) Clearance

Also marketed or referenced as:
CHEMISTRY ELECTROLYTES KIT CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR

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

K080404 · Medica Corp. · Chemistry device
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Mar 2009
Decision
393d
Days
Class 2
Risk

K080404 is an FDA 510(k) clearance for the EASYQC - CHEMISTRY WITH ELECTROLYTES. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on March 13, 2009 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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. Elevated predicate reliance profile. 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 K080404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2008
Decision Date March 13, 2009
Days to Decision 393 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
305d slower than avg
Panel avg: 88d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.