Cleared Traditional

K120064 - TEST

K120064 is an FDA 510(k) clearance for TEST, manufactured by Hmd Biomedical, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K120064

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.

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

All 275
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K120064.
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