Cleared Traditional

K142035 - GLUCOCARD 01-MINI BLOOD GLUCOSE MONITOR...

K142035 is the FDA 510(k) clearance for GLUCOCARD 01-MINI BLOOD GLUCOSE MONITOR... by Arkray Factory, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K142035 · Arkray Factory, Inc. · Chemistry device
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Sep 2014
Decision
39d
Days
Class 2
Risk

K142035 is an FDA 510(k) clearance for the GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Arkray Factory, Inc. (Edina, US). The FDA issued a Cleared decision on September 5, 2014 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arkray Factory, Inc. devices

Submission Details

510(k) Number K142035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date September 05, 2014
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K142035.
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K140371 · Abbott Diabetes Care, Inc. · Sep 2014
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K133741 · Roche Diagnostics · Aug 2014
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K130265 · Bayer Healthcare, LLC · Jun 2014
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K133790 · Andon Health Co, Ltd. · May 2014