Cleared Special

K060793 - ELEMENT BLOOD GLUCOSE TEST SYSTEM

K060793 is an FDA 510(k) clearance for ELEMENT BLOOD GLUCOSE TEST SYSTEM, manufactured by Home Diagnostics, Inc.. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K060793

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 89d · This submission: 124d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K060793.
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K062058 · Bayer Healthcare · 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
PRODIGY BLOOD GLUCOSE TEST SYSTEM
K060467 · Diagnostic Devices, Inc. · Jul 2006
PRODIGY
K053593 · Diagnostic Devices, Inc. · Jul 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation · Jul 2006
K060793 · ELEMENT BLOOD GLUCOSE TEST SYSTEM
Download PDF Home Diagnostics, Inc.