Cleared Special

K133537 - EGV1.1 SELF MONITORING BLOOD GLUCOSE SY...

K133537 is an FDA 510(k) clearance for EGV1.1 SELF MONITORING BLOOD GLUCOSE SY..., manufactured by Eps Bio Technology Corp.. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 161-day FDA review.

K133537 · Eps Bio Technology Corp. · Chemistry device
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Apr 2014
Decision
161d
Days
Class 2
Risk

K133537 is an FDA 510(k) clearance for the EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD G.... Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 28, 2014 after a review of 161 days - an extended review 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. Standard predicate reliance. 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 - K133537

510(k) Number K133537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date April 28, 2014
Days to Decision 161 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 88d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 56
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K133537.
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
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K120042 · Taidoc Technology Corporation · May 2012
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K121207 · Eps Bio Technology Corp. · May 2012