Cleared Special

K103021 - ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM

K103021 is an FDA 510(k) clearance for ELEMENT PLUS BLOOD GLUCOSE MONITORING S..., manufactured by Infopia Co, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 388-day FDA review.

K103021 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
388d
Days
Class 2
Risk

K103021 is an FDA 510(k) clearance for the ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Fullerton, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K103021

510(k) Number K103021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date November 04, 2011
Days to Decision 388 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 89d · This submission: 388d
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
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K103021 · ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Infopia Co, Ltd.