Cleared Special

K113670 - ELEMENT BLOOD GLUCOSE MONITORING SYSTEM

K113670 is an FDA 510(k) clearance for ELEMENT BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Infopia Co, Ltd.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 147-day FDA review.

K113670 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
147d
Days
Class 2
Risk

K113670 is an FDA 510(k) clearance for the ELEMENT BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 147 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 - K113670

510(k) Number K113670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2011
Decision Date May 08, 2012
Days to Decision 147 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
58d slower than avg
Panel avg: 89d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K113670.
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
K121654 · I-Sens, Inc. · Sep 2012
CLEVER CHOICE
K120921 · Simple Diagnostics, Inc. · Aug 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
K120759 · I-Sens, Inc. · Jun 2012
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
K103230 · Bestgen Biotech Corp. · Apr 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
K120448 · Apex BioTechnology Corp. · Apr 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
K113547 · Apex BioTechnology Corp. · Mar 2012
K113670 · ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Infopia Co, Ltd.