Cleared Special

K100398 - SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

K100398 is an FDA 510(k) clearance for SMARTLINK GOLD BLOOD GLUCOSE MONITORING..., manufactured by Standard Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 113-day FDA review.

K100398 · Standard Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
113d
Days
Class 2
Risk

K100398 is an FDA 510(k) clearance for the SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Standard Diagnostics, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 9, 2010 after a review of 113 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.

FDA 510(k) Submission Details - K100398

510(k) Number K100398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date June 09, 2010
Days to Decision 113 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
25d slower than avg
Panel avg: 88d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

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 510
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K100398 · SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Standard Diagnostics,…