Cleared Traditional

K080404 - EASYQC - CHEMISTRY WITH ELECTROLYTES

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

K080404 is an FDA 510(k) clearance for EASYQC - CHEMISTRY WITH ELECTROLYTES, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K080404 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K080404

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
Combination Product No
PCCP Authorized No
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.

JIX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 264
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