Cleared Special

K143750 - MEG-2B Blood Glucose Monitoring System

K143750 is the FDA 510(k) clearance for MEG-2B Blood Glucose Monitoring System by Apex BioTechnology Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 127-day FDA review.

K143750 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
127d
Days
Class 2
Risk

K143750 is an FDA 510(k) clearance for the MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring S.... 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 May 7, 2015 after a review of 127 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 Apex BioTechnology Corp. devices

Submission Details

510(k) Number K143750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2014
Decision Date May 07, 2015
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K143750.
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · Instrumentation Laboratory CO · Dec 2016
GEM Premier 3000
K161818 · Instrumentation Laboratory CO · Sep 2016
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
K142689 · Apex BioTechnology Corp. · Aug 2015
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750 · Apex BioTechnology Corp. · Mar 2014
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · ACON Laboratories, Inc. · Nov 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
K120448 · Apex BioTechnology Corp. · Apr 2012