Cleared Traditional

TEST, BLOOD GLUCOSE SYSTEM (K120064) - FDA 510(k) Clearance

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

K120064 · Hmd Biomedical, Inc. · Chemistry device
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Sep 2012
Decision
240d
Days
Class 2
Risk

K120064 is an FDA 510(k) clearance for the TEST, BLOOD GLUCOSE SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on September 5, 2012 after a review of 240 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 K120064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2012
Decision Date September 05, 2012
Days to Decision 240 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
152d slower than avg
Panel avg: 88d · This submission: 240d
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 166
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K120064.
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp. · Mar 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · Roche Diagnostics · Feb 2013
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
K121679 · Roche Diagnostics · Oct 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · Taidoc Technology Corporation · Aug 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
K111890 · Taidoc Technology Corporation · Feb 2012
GLUCOSE TEST SYSTEM
K113137 · Roche Diagnostics · Jan 2012