Cleared Traditional

K052818 - EZ SMART-168 GLUCOSE MONITORING SYSTEM

K052818 is an FDA 510(k) clearance for EZ SMART-168 GLUCOSE MONITORING SYSTEM, manufactured by Tyson Bioresearch, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K052818 · Tyson Bioresearch, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
255d
Days
Class 2
Risk

K052818 is an FDA 510(k) clearance for the EZ SMART-168 GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Tyson Bioresearch, Inc. (Washington, US). The FDA issued a Cleared decision on June 16, 2006 after a review of 255 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. 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.

FDA 510(k) Submission Details - K052818

510(k) Number K052818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date June 16, 2006
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 89d · This submission: 255d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K052818.
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THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · E-San Limited · Jun 2006
GLUCOPACK
K052469 · Healthpia America Corp. · Jun 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · Lifescan, Inc. · May 2006
K052818 · EZ SMART-168 GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Tyson Bioresearch, In…