Cleared Traditional

K023279 - GLUCOLEADER VALUE (FDA 510(k) Clearance)

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

K023279 · Hmd Biomedical, Inc. · Chemistry device

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Aug 2003

Decision

307d

Days

Class 2

Risk

K023279 is an FDA 510(k) clearance for the GLUCOLEADER VALUE. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Hmd Biomedical, Inc. (Ocean, US). The FDA issued a Cleared decision on August 4, 2003 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 Hmd Biomedical, Inc. devices

Submission Details

510(k) Number	K023279 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 01, 2002
Decision Date	August 04, 2003
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement
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.