Cleared Traditional

EASYRA DLDL REAGENT, CALIBRATOR (K090734) - FDA 510(k) Clearance

Also marketed or referenced as:
EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES

Class I Chemistry device.

K090734 · Medica Corp. · Chemistry device
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Jul 2009
Decision
120d
Days
Class 1
Risk

K090734 is an FDA 510(k) clearance for the EASYRA DLDL REAGENT, CALIBRATOR. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on July 17, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 K090734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date July 17, 2009
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRR System, Test, Low Density, Lipoprotein
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.