Cleared Traditional

EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971) - FDA 510(k) Clearance

Class I Chemistry device.

K990971 · Medica Corp. · Chemistry device
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Apr 1999
Decision
35d
Days
Class 1
Risk

K990971 is an FDA 510(k) clearance for the EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 27, 1999 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medica Corp. devices

Submission Details

510(k) Number K990971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date April 27, 1999
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.