Cleared Special

K081715 - FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM

K081715 is an FDA 510(k) clearance for FORA TD-4244 & TD-4245 BLOOD GLUCOSE MO..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 182-day FDA review.

K081715 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
182d
Days
Class 2
Risk

K081715 is an FDA 510(k) clearance for the FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 17, 2008 after a review of 182 days - an extended review 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. 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 - K081715

510(k) Number K081715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date December 17, 2008
Days to Decision 182 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 89d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K081715.
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
K083099 · Eps Bio Technology Corp. · Jan 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
K081703 · Entra Health Systems, Ltd. · Jan 2009
ENVISION BLOOD GLUCOSE TEST SYSTEM
K082020 · Infopia Co, Ltd. · Dec 2008
PRO GLUCOSE TEST STRIP
K082169 · Taidoc Technology Corporation · Dec 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
K081975 · Abbott Diabetes Care, Inc. · Nov 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
K082513 · Lifescan, Inc. · Oct 2008
K081715 · FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
Download PDF Taidoc Technology Cor…