Cleared Special

K112275 - FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM

K112275 is an FDA 510(k) clearance for FORA PREMIUM V10 BLOOD GLUCOSE MONITORI..., 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 129-day FDA review.

K112275 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
129d
Days
Class 2
Risk

K112275 is an FDA 510(k) clearance for the FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM. 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 15, 2011 after a review of 129 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 Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K112275

510(k) Number K112275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2011
Decision Date December 15, 2011
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 327
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K112275.
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098 · Apex BioTechnology Corp. · Jan 2012
GLUCOSE TEST SYSTEM
K113137 · Roche Diagnostics · Jan 2012
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · Taidoc Technology Corporation · Dec 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
K103544 · Agamatrix, Inc. · Dec 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
K112963 · Taidoc Technology Corporation · Nov 2011
IGLUCOSE SYSTEM
K111932 · Positiveid Corporation · Nov 2011