Cleared Special

K081451 - RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K081451 is the FDA 510(k) clearance for RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM by Bionime Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 118-day FDA review.

K081451 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
118d
Days
Class 2
Risk

K081451 is an FDA 510(k) clearance for the RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bionime Corporation (Great Neck, US). The FDA issued a Cleared decision on September 18, 2008 after a review of 118 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bionime Corporation devices

Submission Details

510(k) Number K081451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date September 18, 2008
Days to Decision 118 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

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
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