Cleared Special

K142336 - GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K142336 · Arkray Factory, Inc. · Chemistry device
Sep 2014
Decision
27d
Days
Class 2
Risk

K142336 is an FDA 510(k) clearance for the GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Mon.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Arkray Factory, Inc. (Koka-Shi, JP). The FDA issued a Cleared decision on September 17, 2014 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K142336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2014
Decision Date September 17, 2014
Days to Decision 27 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
207d faster than avg
Panel avg: 234d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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.