Cleared Special

K011233 - MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

K011233 is an FDA 510(k) clearance for MODIFICATION TO GLUCOSURE BGM 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 25-day FDA review.

K011233 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
25d
Days
Class 2
Risk

K011233 is an FDA 510(k) clearance for the MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Edina, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 25 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.

FDA 510(k) Submission Details - K011233

510(k) Number K011233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date May 18, 2001
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 K011233.
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953 · Wiener Laboratories Saic · Dec 2001
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K011479 · Inverness Medical Innovations, Inc. · Nov 2001
BIOSCANNER 2000
K013068 · Polymer Technology Systems, Inc. · Nov 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · Instrumentation Laboratory CO · May 2001
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
K010605 · Amira Medical, Inc. · May 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd. · Mar 2001
K011233 · MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
Download PDF FDA Summary Apex BioTechnology Co…