Cleared Abbreviated

K111996 - ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 (FDA 510(k) Clearance)

Class I Chemistry device.

K111996 · Elitechgroup · Chemistry device
Sep 2011
Decision
63d
Days
Class 1
Risk

K111996 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 63 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K111996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2011
Decision Date September 14, 2011
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
171d faster than avg
Panel avg: 234d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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.