Cleared Special

K143750 - MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System

K143750 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 127-day FDA review.

K143750 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K143750

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
38d slower than avg
Panel avg: 89d · This submission: 127d
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 K143750.
ABL80 FLEX and ABL80 FLEX CO-OX
K151639 · Sendx Medical, Inc. · Dec 2015
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
K142689 · Apex BioTechnology Corp. · Aug 2015
CardioChek Plus Test System
K151530 · Polymer Technology Systems, Inc. · Jul 2015
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
K142302 · Polymer Technology Systems, Inc. · Oct 2014
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
K142336 · Arkray Factory, Inc. · Sep 2014
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
K133584 · Eoshealth, Inc. · Sep 2014
K143750 · MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
Download PDF FDA Summary Apex BioTechnology Co…