Cleared Special

K082121 - EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 (FDA 510(k) Clearance)

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

K082121 · Eps Bio Technology Corp. · Chemistry device
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Sep 2008
Decision
51d
Days
Class 2
Risk

K082121 is an FDA 510(k) clearance for the EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005. 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 17, 2008 after a review of 51 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 K082121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date September 17, 2008
Days to Decision 51 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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.

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