Cleared Traditional

K081703 - MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS

K081703 is an FDA 510(k) clearance for MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS, manufactured by Entra Health Systems, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K081703 · Entra Health Systems, Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2009
Decision
205d
Days
Class 2
Risk

K081703 is an FDA 510(k) clearance for the MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Entra Health Systems, Ltd. (Pleasanton, US). The FDA issued a Cleared decision on January 8, 2009 after a review of 205 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.

View all Entra Health Systems, Ltd. devices

FDA 510(k) Submission Details - K081703

510(k) Number K081703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date January 08, 2009
Days to Decision 205 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
117d slower than avg
Panel avg: 88d · This submission: 205d
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 280
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