Cleared Traditional

K092104 - ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

K092104 is an FDA 510(k) clearance for ASSURE PLATINUM BLOOD GLUCOSE MONITORIN..., manufactured by Arkray Factory USA, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K092104 · Arkray Factory USA, Inc. · Chemistry device
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Nov 2009
Decision
133d
Days
Class 2
Risk

K092104 is an FDA 510(k) clearance for the ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Arkray Factory USA, Inc. (Edina, US). The FDA issued a Cleared decision on November 24, 2009 after a review of 133 days - within the typical 510(k) review window.

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 - K092104

510(k) Number K092104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date November 24, 2009
Days to Decision 133 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
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 263
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