Cleared Special

K093506 - CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267

K093506 is an FDA 510(k) clearance for CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCO..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 140-day FDA review.

K093506 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
140d
Days
Class 2
Risk

K093506 is an FDA 510(k) clearance for the CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 1, 2010 after a review of 140 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 - K093506

510(k) Number K093506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2009
Decision Date April 01, 2010
Days to Decision 140 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
52d slower than avg
Panel avg: 88d · This submission: 140d
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 384
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K093506.
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405 · Taidoc Technology Corporation · Jul 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406 · Taidoc Technology Corporation · May 2010
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
K100187 · Medica Corp. · May 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941 · Taidoc Technology Corporation · Mar 2010
INTEGRATED LABORATORY AUTOMATION SOLUTION
K091975 · Integrated Laboratory Automation Solutions, Inc. · Mar 2010
DS-A BLOOD GLUCOSE MONITORING SYSTEM
K082965 · Alliance International Co., Ltd. · Dec 2009
K093506 · CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
Download PDF FDA Summary Taidoc Technology Cor…