Cleared Special

K100405 - FORA G90 PERFORM BLOOD GLUCOSE MONITORI...

K100405 is the FDA 510(k) clearance for FORA G90 PERFORM BLOOD GLUCOSE MONITORI... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 143-day FDA review.

K100405 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
143d
Days
Class 2
Risk

K100405 is an FDA 510(k) clearance for the FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on July 9, 2010 after a review of 143 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

Submission Details

510(k) Number K100405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date July 09, 2010
Days to Decision 143 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
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 145
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K100405.
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · ACON Laboratories, Inc. · Nov 2012
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · ACON Laboratories, Inc. · Oct 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842 · Beckman Coulter, Inc. · Apr 2011
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 AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506 · Taidoc Technology Corporation · Apr 2010