Cleared Traditional

K161790 - iGlucose Blood Glucose Monitoring System

K161790 is the FDA 510(k) clearance for iGlucose Blood Glucose Monitoring System by Bionime Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K161790 · Bionime Corporation · Chemistry device
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May 2017
Decision
307d
Days
Class 2
Risk

K161790 is an FDA 510(k) clearance for the iGlucose Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Corporation (Taichung City, TW). The FDA issued a Cleared decision on May 2, 2017 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bionime Corporation devices

Submission Details

510(k) Number K161790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2016
Decision Date May 02, 2017
Days to Decision 307 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
219d slower than avg
Panel avg: 88d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K161790.
StatStrip Xpress Blood Glucose Monitoring System
K170464 · Nova Biomedical Corporation · Nov 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · Abbott Diabetes Care, Inc. · Sep 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · Andon Health Co, Ltd. · Sep 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · Taidoc Technology Corporation · Apr 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · Apex BioTechnology Corp. · Mar 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
K153561 · Andon Health Co, Ltd. · Feb 2017