Cleared Special

K060793 - ELEMENT BLOOD GLUCOSE TEST SYSTEM

K060793 is the FDA 510(k) clearance for ELEMENT 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 124-day FDA review.

K060793 · Home Diagnostics, Inc. · Chemistry device
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Jul 2006
Decision
124d
Days
Class 2
Risk

K060793 is an FDA 510(k) clearance for the ELEMENT 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 25, 2006 after a review of 124 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 Home Diagnostics, Inc. devices

Submission Details

510(k) Number K060793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2006
Decision Date July 25, 2006
Days to Decision 124 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
36d slower than avg
Panel avg: 88d · This submission: 124d
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 K060793.
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM
K062235 · Taidoc Technology Corporation · Sep 2006
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K062195 · Lifescan, Inc. · Aug 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp. · Aug 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation · Jul 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · Lifescan, Inc. · May 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · Abbott Diabetes Care, Inc. · Mar 2006