Cleared Special

K051147 - SIDEKICK BLOOD GLUCOSE TEST SYSTEM

K051147 is the FDA 510(k) clearance for SIDEKICK BLOOD GLUCOSE TEST SYSTEM by Home Diagnostics, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 69-day FDA review.

K051147 · Home Diagnostics, Inc. · Chemistry device
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Jul 2005
Decision
69d
Days
Class 2
Risk

K051147 is an FDA 510(k) clearance for the SIDEKICK BLOOD GLUCOSE TEST SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on July 12, 2005 after a review of 69 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 Home Diagnostics, Inc. devices

Submission Details

510(k) Number K051147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date July 12, 2005
Days to Decision 69 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K051147.
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K051802 · Abbott Diabetes Care, Inc. · Aug 2005
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
K051936 · Taidoc Technology Corporation · Aug 2005
CLEVER CHEK TD-4225, MODEL TD-4225
K051854 · Taidoc Technology Corporation · Aug 2005
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
K050500 · Abbott Diabetes Care, Inc. · Jun 2005
CLEVER CHEK TD-3213
K042795 · Taidoc Technology Corporation · Mar 2005
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · Bayer Healthcare, LLC · Dec 2004