Cleared Special

K072543 - ONETOUCH SELECT BLOOD GLUCOSE MONITORIN...

K072543 is the FDA 510(k) clearance for ONETOUCH SELECT BLOOD GLUCOSE MONITORIN... by Lifescan, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 25-day FDA review.

K072543 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
25d
Days
Class 2
Risk

K072543 is an FDA 510(k) clearance for the ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 25 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lifescan, Inc. devices

Submission Details

510(k) Number K072543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date October 05, 2007
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
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 183
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