Cleared Special

K061992 - EASYPLUS SELF MONITORING GLUCOSE TEST S...

K061992 is an FDA 510(k) clearance for EASYPLUS SELF MONITORING GLUCOSE TEST S..., manufactured by Eps Bio Technology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 68-day FDA review.

K061992 · Eps Bio Technology Corp. · Chemistry device
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Sep 2006
Decision
68d
Days
Class 2
Risk

K061992 is an FDA 510(k) clearance for the EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Hsinchu City, TW). The FDA issued a Cleared decision on September 19, 2006 after a review of 68 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.

View all Eps Bio Technology Corp. devices

FDA 510(k) Submission Details - K061992

510(k) Number K061992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2006
Decision Date September 19, 2006
Days to Decision 68 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 231
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K061992.
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K061528 · Card Guard Scientific Survival , Ltd. · Sep 2006
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K060345 · Nova Biomedical Corp. · Apr 2006
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ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · Lifescan, Inc. · May 2005