Cleared Traditional

K143387 - GE333 Blood Glucose Monitoring System

K143387 is an FDA 510(k) clearance for GE333 Blood Glucose Monitoring System, manufactured by Bionime Coporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K143387 · Bionime Coporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
189d
Days
Class 2
Risk

K143387 is an FDA 510(k) clearance for the GE333 Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Coporation (Taichung City, TW). The FDA issued a Cleared decision on June 3, 2015 after a review of 189 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 Bionime Coporation devices

FDA 510(k) Submission Details - K143387

510(k) Number K143387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date June 03, 2015
Days to Decision 189 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
101d slower than avg
Panel avg: 88d · This submission: 189d
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 Consultant

Ivdd Regulatory Consultant
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K143387.
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
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Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30
K140150 · Hmd Biomedical, Inc. · May 2015