Cleared Traditional

K040678 - EUSURE BLOOD GLUCOSE MONITORING SYSTEM

K040678 is an FDA 510(k) clearance for EUSURE BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Eumed Biotechnology Co., Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K040678 · Eumed Biotechnology Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
121d
Days
Class 2
Risk

K040678 is an FDA 510(k) clearance for the EUSURE BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Eumed Biotechnology Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on July 14, 2004 after a review of 121 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 Eumed Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K040678

510(k) Number K040678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2004
Decision Date July 14, 2004
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
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 316
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K040678.
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · Bayer Healthcare, LLC · Dec 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · Taidoc Technology Corporation · Aug 2004
PTS PANELS CHOL+GLU TEST PANEL
K041750 · Polymer Technology Systems, Inc. · Jul 2004
TAIDOC CHECK
K041107 · Taidoc Technology Corporation · Jun 2004
PARADIGM LINK BLOOD GLUCOSE METER
K040603 · Becton, Dickinson & CO · May 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories · Apr 2004