Cleared Special

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 (K061992) - FDA 510(k) Clearance

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

K061992 · Eps Bio Technology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 104
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