Cleared Traditional

K090332 - ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001

K090332 is an FDA 510(k) clearance for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Arkray Factory USA, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K090332 · Arkray Factory USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
185d
Days
Class 2
Risk

K090332 is an FDA 510(k) clearance for the ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Arkray Factory USA, Inc. (Edina, US). The FDA issued a Cleared decision on August 14, 2009 after a review of 185 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 Arkray Factory USA, Inc. devices

FDA 510(k) Submission Details - K090332

510(k) Number K090332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date August 14, 2009
Days to Decision 185 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
97d slower than avg
Panel avg: 88d · This submission: 185d
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 310
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