Cleared Traditional

K113314 - PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (FDA 510(k) Clearance)

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

K113314 · Hmd Biomedical, Inc. · Chemistry device
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Nov 2012
Decision
366d
Days
Class 2
Risk

K113314 is an FDA 510(k) clearance for the PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on November 9, 2012 after a review of 366 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 K113314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date November 09, 2012
Days to Decision 366 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
278d slower than avg
Panel avg: 88d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFR Glucose Dehydrogenase, Glucose
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.