Cleared Traditional

K182428 - GlucoLeader Enhance Blood Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182428 · Hmd Biomedical, Inc. · Chemistry device

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May 2019

Decision

244d

Days

Class 2

Risk

K182428 is an FDA 510(k) clearance for the GlucoLeader Enhance Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Hmd Biomedical, Inc. (Hsin Chu County, TW). The FDA issued a Cleared decision on May 8, 2019 after a review of 244 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 Hmd Biomedical, Inc. devices

Submission Details

510(k) Number	K182428 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 2018
Decision Date	May 08, 2019
Days to Decision	244 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

156d slower than avg

Panel avg: 88d · This submission: 244d

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.