Cleared Traditional

K113314 - PRECICHEK NS-101 POCT PROFESSIONAL BLOO...

K113314 is an FDA 510(k) clearance for PRECICHEK NS-101 POCT PROFESSIONAL BLOO..., manufactured by Hmd Biomedical, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 366-day FDA review.

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

FDA 510(k) Submission Details - K113314

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.

LFR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 57
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K113314.
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GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
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CONTOUR NEXT BLOOD GLUCOSE METER
K121190 · Bayer Healthcare, LLC · Jul 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K120042 · Taidoc Technology Corporation · May 2012