Cleared Traditional

K053312 - EASYMATE BLOOD GLUCOSE MONITORING SYSTEM

K053312 is an FDA 510(k) clearance for EASYMATE BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Bioptik Technology, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K053312 · Bioptik Technology, Inc. · Chemistry device
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Mar 2006
Decision
93d
Days
Class 2
Risk

K053312 is an FDA 510(k) clearance for the EASYMATE BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bioptik Technology, Inc. (Plano, US). The FDA issued a Cleared decision on March 1, 2006 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioptik Technology, Inc. devices

FDA 510(k) Submission Details - K053312

510(k) Number K053312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2005
Decision Date March 01, 2006
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 325
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K053312.
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
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G4, MODEL IGM-0004
K051651 · U. S. Diagnostics, Inc. · Apr 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · Abbott Diabetes Care, Inc. · Mar 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · Bionime Corporation · Feb 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · Lifescan, Inc. · Jan 2006
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K051802 · Abbott Diabetes Care, Inc. · Aug 2005