Cleared Special

K120448 - MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

K120448 is an FDA 510(k) clearance for MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Apex BioTechnology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 52-day FDA review.

K120448 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
52d
Days
Class 2
Risk

K120448 is an FDA 510(k) clearance for the MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, .... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 6, 2012 after a review of 52 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 Apex BioTechnology Corp. devices

FDA 510(k) Submission Details - K120448

510(k) Number K120448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2012
Decision Date April 06, 2012
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K120448.
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
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670 · Infopia Co, Ltd. · May 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
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · Apex BioTechnology Corp. · Jan 2012
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278 · I-Sens, Inc. · Oct 2011